Walgreens Kit
FDA Label NDC 0363-1500

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Walgreens (NDC 0363-1500). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding contents – walgreens all-purpose first aid kit, active ingredient (in each caplet)– diphen allergy caplet, purpose – diphen allergy caplet, uses – diphen allergy caplet, warnings – diphen allergy caplet, do not use – diphen allergy caplet, ask a doctor before use if you have – diphen allergy caplet, ask a doctor or pharmacist before use if you are – diphen allergy caplet, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Contents – Walgreens All-Purpose First Aid Kit

BANDAGES

40 – Sheer Bandages 3/4 IN x 3 IN (19 mm x 76 mm) (MADE IN U.S.A. WITH GLOBALLY SOURCED MATERIALS)

40 – Sheer Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm) (MADE IN U.S.A. WITH GLOBALLY SOURCED MATERIALS)

12 – Waterproof Bandages 3/4 IN x 2 IN (19 mm x 50 mm) (MADE IN U.S.A. WITH GLOBALLY SOURCED MATERIALS)

8 – Butterfly Closures 1 3/4 IN x 3/8 IN (44 mm x 9 mm) (MADE IN U.S.A. WITH GLOBALLY SOURCED MATERIALS)

10 – Fabric Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm) (MADE IN U.S.A. WITH GLOBALLY SOURCED MATERIALS)

3 – Fabric Knuckle Bandages 1 1/2 IN x 3 IN (38 mm x 76 mm) (MADE IN U.S.A. WITH GLOBALLY SOURCED MATERIALS)

INSTRUMENTS

2 – Wooden Finger Splints (MADE IN U.S.A. WITH GLOBALLY SOURCED MATERIALS)

1 – Paper Tape 1/2 IN x 5 YD (12.7 mm x 4.5 m) (MADE IN CHINA)

1 – Metal Tweezers (MADE IN CHINA)

1 – Single-Use Instant Cold Pack (MADE IN CHINA)

1 – First Aid Guide (MADE IN U.S.A.)

1 – Carrying Case (MADE IN MEXICO)

TOPICALS and MEDICINES

4 – Alcohol Prep Pads 13/16 IN x 2 5/16 IN (30 mm x 58 mm) (MADE IN CHINA)

5 – Antiseptic Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm) (MADE IN U.S.A.)

4 – Ibuprofen Tablets 2 PER PACKET (MADE IN CHINA)

2 – Allergy Caplets 1 PER PACKET (MADE IN CHINA)

3 – Triple Antibiotic Ointments 1/32 OZ (0.9 g) (MADE IN U.S.A. WITH GLOBALLY SOURCED MATERIALS)

2 – Hydrocortisone Cream 1/32 OZ (0.9 g) (MADE IN U.S.A. WITH GLOBALLY SOURCED MATERIALS)

1 – First Aid & Burn Cream 1/32 OZ (0.9 g) (MADE IN U.S.A. WITH GLOBALLY SOURCED MATERIALS)

WOUND DRESSINGS

5 – Gauze Pads 2 IN x 2 IN (50 mm x 50 mm) (MADE IN CHINA)

3 – Non-stick* Pads 2 IN x 3 IN (50 mm x 76 mm) (MADE IN CHINA)

2 – Gauze Pads 4 IN x 4 IN (101 mm x 101 mm) (MADE IN CHINA)

Ibuprofen, Alcohol Prep Pads, Allergy Caplets, First Aid & Burn Cream, Hydrocortisone Cream, Triple Antibiotic Ointment & Antiseptic Wipes

CAUTION: This product contains non-prescription drug products that have expiration dates. Please check before use. Keep these and all drug products out of the reach of children.

Adhesive Bandages: For use on minor cuts, scrapes and burns.Directions: For optimal results, apply bandage to clean, dry skin. Change the dressing daily, when wet or more often if needed. Single use.

WARNING: For medical emergencies, seek professional help.

Waterproof Bandages: For use on minor cuts, scrapes and burns.Directions: For optimal results, apply bandage to clean, dry skin. Change the dressing daily or more often if needed. Single use.

WARNING: For medical emergencies, seek professional help.

Butterfly Closures: For use on minor cuts and wounds.Directions: Remove backing tabs from Butterfly Closure. Apply adhesive sections on either side of the wound. Be sure to center the non-stick area over the wound. Change dressing as directed by your health care professional. Single use.

WARNING: For medical emergencies, seek professional help.

Gauze Pads: For cleaning wounds.Directions: Gently clean the wound with mild soap and water using the gauze pad and carefully dry the affected area. Discard the used pad. Single use.

WARNING: In case of deep puncture wounds or serious burns, consult a physician.

Non-stick* Pads: Ideal for cushioning and protecting minor cuts, scrapes and burns without sticking. Single use.Directions: Carefully cover the wound with a non-stick* pad to help absorb fluid.

*Will not adhere to sutures, staples or adhesive wound closures.

WARNING: In case of deep puncture wounds or serious burns, consult a physician.

Paper Tape: For securing wound covers

Directions: use gauze to gently clean in and around injured area with mild soap and water. Dry injured area and apply medication if necessary. Cover wound with non-stick pad* or dressing. Secure the dressing with paper tape to help keep out dirt and contaminants.

WARNING: In case of deep puncture wounds or serious burns, consult a physician.

Adhesive Bandages, Butterfly Closures, Gauze Pads, Non-Stick Pads, and Waterproof Bandages are sterile unless wrapper is opened or damaged.

Gauze Pads are rayon-polyester blend.

Not nade with natural rubber latex.

Active Ingredient (In Each Caplet)– Diphen Allergy Caplet

Diphenhydramine Hydrochloride 25 mg

Purpose – Diphen Allergy Caplet

Antihistamine

Uses – Diphen Allergy Caplet

Temporarily relieves these symptoms due to hay fever or other respiratory allergies

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

    • Temporarily relieves these symptoms due to the common cold

    • runny nose
    • sneezing

Warnings – Diphen Allergy Caplet

.

Do Not Use – Diphen Allergy Caplet

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one that is used on skin.

Ask A Doctor Before Use If You Have – Diphen Allergy Caplet

  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urinating due to enlargement of the prostate gland
  • glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are – Diphen Allergy Caplet

  • taking sedatives or tranquilizers

When Using This Product – Diphen Allergy Caplet

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If Pregnant Or Breast-Feeding, – Diphen Allergy Caplet

ask a health care professional before use.

Keep Out Of Reach Of Children. – Diphen Allergy Caplet

In case of overdose, contact a physician or poison control center immediately

Directions – Diphen Allergy Caplet

  • take every 4-6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours

    • Adults and children: (12 years and over)1 to 2 caplets

    Children under 12 years:do not use

Other Information – Diphen Allergy Caplet

  • protect from light
  • store at room temperature 68°-77°F (20°-25°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients – Diphen Allergy Caplet

croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Active Ingredients – Antiseptic Wipes

Ethyl Alcohol 66.5%

Purpose – Antiseptic Wipes

Antiseptic

Uses – Antiseptic Wipes

Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water

Warnings – Antiseptic Wipes

For external use only
Flammable: keep away from fire or flame

Do Not Use – Antiseptic Wipes

in the eyes. If this happens, rinse thoroughly with water.

Stop Use And Ask A Doctor – Antiseptic Wipes

if irritation or redness develop and persist for more than 72 hours

Keep Out Of Reach Of Children – Antiseptic Wipes

If swallowed get medical help or contact a Poison Control Center right away

Directions – Antiseptic Wipes

  • tear open packet, remove towelette
  • unfold and use as a washcloth
  • supervise children under 6 years of age

Inactive Ingredients – Antiseptic Wipes

aloe vera, fragrance, purified water, triethanolamine

Active Ingredient (In Each Gram) – Triple Antibiotic Ointment

Bacitracin Zinc (400 units Bacitracin)
Neomycin Sulfate (3.5 mg Neomycin)
Polymyxin B Sulfate (Polymyxin B 5000 units)

Purpose – Triple Antibiotic Ointment

First Aid Antibiotic
First Aid Antibiotic
First Aid Antibiotic

Uses – Triple Antibiotic Ointment

first aid to help prevent infection in minor cuts, scrapes, and burns

Warnings – Triple Antibiotic Ointment

For external use only

Do Not Use – Triple Antibiotic Ointment

  • internally
  • in eyes
  • over large areas of the body
  • for more than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients

Stop Use And Ask A Doctor If – Triple Antibiotic Ointment

  • a rash or allergic reaction develops
  • the condition persists or gets worse

Keep Out Of Reach Of Children – Triple Antibiotic Ointment

In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Directions – Triple Antibiotic Ointment

  • Clean the affected area
  • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • May be covered with a sterile bandage

Inactive Ingredients – Triple Antibiotic Ointment

petrolatum

Active Ingredient – First Aid And Burn Cream

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Purpose – First Aid And Burn Cream

First Aid Antiseptic

Topical Analgesic

Uses – First Aid And Burn Cream

  • temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria

Warnings – First Aid And Burn Crean

For external use only

Do Not Use – First Aid And Burn Crean

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor

Stop Use, Ask A Doctor – First Aid And Burn Crean

  • condition worsens or if symptoms persist for more than 7 days or clear up and occurs again within a few days

Keep Out Of Reach Of Children. – First Aid And Burn Cream

If ingested, contact a Poison Control Center right away

Directions – First Aid And Burn Cream

  • clean affected area
  • apply small amount not more than 3 times daily
  • children under 2: consult a doctor

Inactive Ingredients – First Aid And Burn Cream

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Active Ingredient – Alcohol Prep Pads

Isopropyl Alcohol 70%

Purpose – Alcohol Prep Pads

Antiseptic

Uses – Alcohol Prep Pads

  • For preparation of the skin prior to an injection

Warnings – Alcohol Prep Pads

For external use only
Flammable, keep away from fire or flame

Do Not Use – Alcohol Prep Pads

  • with electrocautery procedures
  • in the eyes. If contact occurs, flush eyes with water.

Stop Use If – Alcohol Prep Pads

irritation and redness develop. If condition continues, consult your health care practitioner

Keep Out Of Reach Of Children. – Alcohol Prep Pads

If swallowed get medical help or contact a Poison Control Center right away.

Directions – Alcohol Prep Pads

  • wipe injection area and discard

Other Information – Alcohol Prep Pads

  • Store at room temperature: 59°F - 86°F (15°C - 30°C)

Inactive Ingredient – Alcohol Prep Pads

purified water

Active Ingredient – Hydrocortisone Cream

Hydrocortisone 1.0%

Purpose – Hydrocortisone Cream

Anti-itch

Uses – Hydrocortisone Cream

  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings – Hydrocortisone Cream

For external use only

Do Not Use – Hydrocortisone Cream

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching
  • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • with any other Hydrocortisone product unless you have consulted a doctor

Keep Out Of Reach Of Children. – Hydrocortisone Cream

If swallowed, get medical help or contact a Poison Control Center right away.

Directions – Hydrocortisone Cream

  • for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 12 years of age: for external anal itching, consult a doctor

Inactive Ingredients – Hydrocortisone Cream

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Active Ingredient ( In Each Tablet) – Ibuprofen

Ibuprofen 200 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

Purpose – Ibuprofen

Pain reliever/fever reducer

Uses – Ibuprofen

Temporarily relieves minor aches and pains associated with

• headache • toothache • backache • menstrual cramps • common cold • muscular aches • minor arthritis pain

Temporarily reduces fever.

Warnings – Ibuprofen

Allergy alert:Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
• hives • skin reddening • asthma (wheezing) • facial swelling • rash • shock • blisters
If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Heart attack or stroke warning:NSAIDS, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do Not Use – Ibuprofen

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask A Doctor Before Use If – Ibuprofen

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • stomach bleeding warning applies to you
  • you have a history of stomach problems such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
  • you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are – Ibuprofen

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor’s care for any serious condition
  • taking any other drug

When Using This Product – Ibuprofen

  • take with food or milk if stomach upset occurs

Stop Use And Ask A Doctor If – Ibuprofen

• you experience any of the following signs of stomach bleeding

  • feel faint • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better

    • • you have symptoms of heart problems or stroke

    • chest pain • trouble breathing
    • weakness in one part or side of body
    • slurred speech • leg swelling

      • • pain gets worse or lasts for more than 10 days
      • fever gets worse or lasts for more than 3 days
      • redness or swelling is present in the painful area
      • any new or unexpected symptoms occur

If Pregnancy Or Breast-Feeding, – Ibuprofen

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out Of Reach Of Children. – Ibuprofen

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions – Ibuprofen

• do not use more than directed
• the smallest effective dose should be used
• do not take longer than 10 days, unless directed by a doctor (see Warnings)

Adults and children: (12 years and older)

Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years:

Ask a doctor

Other Information – Ibuprofen

  • read all product information before using
  • store at 68-77°F (20-25°C)
  • avoid excessive heat 104°F (above 40°C )
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients – Ibuprofen

colloidal silicon dioxide, corn starch, iron oxide red, polyethylene glycol, povidone (K30), sodium starch glycolate, stearic acid, talc, titanium dioxide

Principal Display Panel – Diphen Allergy Caplet

Collect MediBucks See inside flap for more details

Medique®

Diphen

Hay Fever / Allergies

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.
Pull to Open

Antihistamine• Diphenhydramine HCl 25 mg

200 Caplets
(200 x 1)

Tamper Evident Unit Dose Packets

Image-02-dephen (Image 02)

Image-02-dephen (Image 02)

Label

Principal Display Panel – Antiseptic Wipes

Safetec

Antiseptic
Towelette

For Professional and Hospital Use
Contents: 1 single-use, premoistened towelette

Manufactured by SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 800-456-7077 www.safetec.com

Image-03 (Image 03)

Image-03 (Image 03)

Label

Principal Display Panel – Triple Antibiotic Ointment

Safetec

Triple Antibiotic
Ointment

0.9 g (1/32 oz.)

Safetec of America, Inc.
Buffalo, NY 14215
800-456-7077

Image-04 (Image 04)

Image-04 (Image 04)

Label

Principal Display Panel – Hydrocortisone Cream

Safetec

1% Hydrocortisone Cream™
0.9 g (1/32 oz.)

Safetec of America, Inc.
Buffalo, NY 14215
800-456-7077

Image-05-hc-cream (Image 05)

Image-05-hc-cream (Image 05)

Label

Principal Display Panel – Alcohol Prep Pads

ALCOHOL
PREP PAD
1 Pad/Pouch
Saturated with 70% Isopropyl Alcohol
For External Use Only

DO NOT REUSE

NOT MADE WITH
NATURAL RUBBER LATEX

Made in China
Manufactured for Aso LLC
Sarasota, Fl 34240 | www.asocorp.com
DIE 40015

Image-06-alcoholpads (Image 06)

Image-06-alcoholpads (Image 06)

Label

Principal Display Panel – First Aid And Burn Cream

Safetec

First Aid and Burn Cream


0.9 g (1/32 oz.)

Safetec of America, Inc.
Buffalo, NY 14215
800-456-7077

Principal Display Panel – Ibuprofen

MEDI-FIRST ®

Ibuprofen 200 mg
100 tablets (50 x 2)

Pain Reliever/Fever Reducer
Aches, Fever • Ibuprofen (NSAID) 200 mg
Pull to Open

Compare active ingredient to:
Advil ®
Registered Trademark of Pfizer Consumer Healthcare
THIS PACKAGE IS FOR HOUSEHOLDS
WITHOUT YOUNG CHILDREN.
Tamper Evident Unit Dose Packets

MEDI-FIRST ®
Reorder #80833
Manufactured for
Medique Products
Fort Myers, FL 33967
1-800-634-7680
www.mediqueproducts.com

Image-08-ibu (Image 08)

Image-08-ibu (Image 08)

Label

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