FDA Label for 25 Person Ansi
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- WARNINGS
- OTC - DO NOT USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- OTC - STOP USE
- OTC - WHEN USING
- INACTIVE INGREDIENT
- DESCRIPTION
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - PREGNANCY OR BREAST FEEDING
- GENERAL PRECAUTIONS
- PEDIATRIC USE
25 Person Ansi Product Label
The following document was submitted to the FDA by the labeler of this product Genuine First Aid Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
ACTIVE INGREDIENTS:
Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%
Active Ingredient: Purpose
Benzalkonium Chloride 0.40%.......... First Aid Antiseptic
Active Ingredient: .........Bacitracin Zinc 400 units
Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)
Polymyxin B Sulfate 5000 units
Active Ingredient:
Purified Water USP...q.s.
Active Ingredient: Purpose:
Benzocaine, 6% w/v.................. Topical Anesthetic
SD alcohol, 60% w/v.................. Antiseptic
Active ingredient (in each tablet) Purpose
Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer
*nonsteroidal anti-inflammatory drug
Active Ingredient (in each tablet) Purpose
Acetaminophen 325 mg ............. Analgesic/antipyretic
Active Ingredient (in each tablet) Purpose
Aspirin (NSAID*) 325 mg............................... Pain Reliever / fever reducer
*nonsteroidal anti-inflammatory drug
Active Ingredient: Purpose
Isopropyl Alcohol, 70% v/v............... Antiseptic
Active Ingredient:
Ethyl Alcohol 62 percent
Genuine Hand Sanitizer
Instant Gel
Antiseptic Handwash
with Vitamin E and Aloe
Kills 99.9 percent of germs
Without Water
Active Ingredient:
Ethyl Alcohol 62 percent
Net Wt 0.9g (1/32 oz)
Manufactured in China For
Genuine First Aid.
Otc - Purpose
Purpose: First aid antiseptic, external analgesic
Uses: First aid to help prevent infection and for the temporary relief of pain and itching associated with:
Minor Cuts
Scrapes
Burns
Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.
Uses: To help prevent infection in:
minor cuts; scrapes; burns
Uses:
For flushing or irrigating the eyes to
remove loose foreign material, air pollutants,
or chlorinated water.
Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.
Uses temporarily relieves minor aches and pains due to:
the common cold
headache
toothache
muscular aches
backache
minor pain of arthritis
menstrual cramps temporarily reduces fever
Uses
temporary relief of minor aches and pains associated with:
common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever
Uses Temporarily relieves minor aches and pains associated with:
headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever
Use: For preparation of skin before injection.
Enter section text here
Warnings
Warnings:
For external use only
Warning: For external use only.
Warnings:
For external use only.
Warning:
If you experience eye pain, changes in vision, continued redness or irritation of the eye,
or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.
Do not use if solution changes color or becomes cloudy.
Warnings: For external use only.
Avoid contact with eyes. If this happens, rinse thoroughly with water.
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 thinner (anticoagulant) or steroid drug, take other drugs containing 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
Warnings:
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This 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 thinner (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
Warnings: For external use only.
Warnings:
For external use only
Flammable, keep away from fire or flame
Otc - Do Not Use
Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week
Do not use in the eyes or over large areas of the body.
Do not use: in eyes; over large areas of the body;
If allergic to any of the ingredients; for more than one week unless directed by a physician.
Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.
Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.
Do not use: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist; for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor
Do not use: if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis
Do not use: with electrocautery, in the eyes.
Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.
Otc - Keep Out Of Reach Of Children
Keep out of reach of Children.
If ingested, contact a Poison Control Center right away.
Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children.
If ingested, contact a Poison
Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt
medical attention is critical for adults as well as for children even if
you do not notice any signs or symptoms. Do not exceed recommended dosage
Keep out of reach of children. In case of overdose, get medical help or
contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions: Clean affected area, Apply small amount not more than 3 times daily.
May be covered with a sterile bandage.
Directions
Remove contacts before using.
Twist top to remove.
Flush the affected area as needed. Control
Rate of flow by pressure on the bottle. Do not touch
tip of the container to any surface. Do not reuse.
If necessary continue flushing with emergency eyewash or shower.
Discard bottle after use.
Directions:
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.
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: Do not give to children under 12 years of age.
Directions
Adults and Children Take 2 tablets every 4 to 6 hours as
12 years of age needed. Do not take more than 12 tablets
or older in 24 hours.
Children 6-11 years Take 1 tablet every 4 to 6 hours as
of age needed. Do not take more than 5
tablets in 24 hours.
Children under 6 Do not use this regular strength product.
years of age This will provide more than the
recommended dose (overdose) and could
cause serious health problems.
Adults and children: (12 years and older) Take 1 or 2 tablets with
water every 4 hours as needed. Do not take more than 12 tablets in 24
hours, or as directed by a doctor.
Children under 12 years: Do not give to children under 12 years of age.
Directions:
Empty contents into palm. Rub hands until gel dissipates. Recommended for repeated use.
Storage And Handling
Other Information:
Store at room temperature
Other information:
Store at room temperature.
Store in a cool place. For irrigation only.
Discard unused portion of the solution.
Not for injection.
Flammable - keep away from fire or flame.
Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets
Store at 59-86 degree Farenheat (15-30 degree Celcius)
Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid
excessive heat and humidity; tamper evident sealed packets;
Do not use any opened or torn packets
Flammable - keep away from fire or flame
Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)
Other Information: Store at 15 to 25 degree Celsius (59 to 77 degree Fahrenheit)
Package Label.Principal Display Panel
Genuine First Aid Burn Cream
Antiseptic Pain Relief With Aloe
Net Wt 0.9g (1/32 oz)
Manufactured in CHINA for
Genuine First Aid.
Antiseptic Towelette
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
Genuine Triple Antibiotic
First Aid Ointment
To Help Prevent Infection
Each Gram Contains:
Bacitracin Zinc 400 units
Neomycin Sulfate 5 mg
(equivalent to 3.5 mg
Neomycin base)
Polymyxin B Sulfate 5000 units
Net Wt. 0.5g ; (1/64 oz)
Manufactured in CHINA for
GENUINE FIRST AID.
10ml
Sterile Isotonic Buffered Genuine
Eyewash
For single use only
Insect Sting Relief Pad
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
IBUPROFEN 2 Tablets
GENUINE FIRST AID 2 Tablets
NON-ASPIRIN
ASPIRIN 2 Tablets
Alcohol Cleansing Pad
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
ANSI/ISEA Z308.1-2009 TYPE III
Caution! This Kit meets ANSI/ISEA Z308.1-2009 only when required minimum
fill is maintained with first aid products marked "ANSI/ISEA
Z308.1-2009."
CARRYING CASE
1 Easy Access Pocket System
1 Hard Case
POCKET1: SMALL CUTS AND BURNS
50 Adhesive Plastic Bandages 1"x3"
1 Knuckle Fabric Bandage
25Adhesive Spot Bandages 7/8"X7/8"
1Fingertrip Fabric Bandage
1 Elbow Knee Adhesive Bandage
6 Burn
Cream
10Antiseptic Towelettes
6 Triple Antibiotic Ointment 0.5gr
20 Cotton Tipped Applicators
POCKET 2: MEDIUM CUTS AND SCRATCHES
10 Antiseptic Towelettes
4 Sterile Gauze Pad 3"x3"
2 Sterile Gauze Pads 4"X4"
2 Roller Gauze Bandage
2"X4.1yds
1 Roller Gauze Bandage 3"X4.1yds
1 Sterile Eye Pads
1 Sterile Eye Wash 10ml Twist
Top
1 Butterfly Wound Closure, Medium
POCKET 3: SEVERE BLEEDING AND BURNS
1 First Aid Tape Roll 1/2"x5
yds.
1 Combine Pad 5"X9"
POCKET 4: CPR
1 CPR Breathing Barrier
POCKET 5: PROTECTION
4 Medical Grade Vinyl Gloves
1 Instant Cold Compress
20 Alcohol Cleansing Pads
1 Hand Sanitizer 0.9g
1 Insect Sting Relief Pads
1 Triangular Bandage
42"x42"x59"
2 Ibuprofen 200mg
2Non Aspirin 325mg
2 Aspirin
325mg
POCKET 6: INSTRUMENTS
1 Emergency First Aid Guide
1 Plastic
Tweezers
1 Scissors
Manufactured in China for:
Genuine
First Aid LLC.
600 Cleveland Street
Suite 400
Clearwater FL
33755
www.GenuineFirstAid.com
GENUINE FIRST AID
Copyright c 2010 Genuine First Aid LLC. All rights reserved.
Otc - Stop Use
Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.
Stop use and consult a doctor:
if the condition persists or gets worse; a rash or other allergic reaction develops
Stop use and ask a doctor If:
you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear
Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs
Stop use and ask a doctor if
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; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear
Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.
Stop use and consult a doctor if irritation and redness develop
and persist for more than 72 hours.
Otc - When Using
Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.
Directions: clean affected area; apply 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
When using this product:
take with food or milk if stomach upset occurs
When using this product: take with food or milk if stomach upset occurs
Directions
do not use more than directed
the smallest effective dose should be used
drink a full glass of water with each dose
do not take longer than 10 days, unless directed by a doctor
Wipe Injection site vigorously and discard.
Inactive Ingredient
Inactive Ingredient: Purified water
Inactive Ingredients:
Sodium Chloride USP 44mg
Monobasic Sodium Phosphate USP 18mg
Sodium Phosphate Dibasic USP 111mg
Edetate Disodium USP 10mg
Benzalkonium Chloride 0.5mg
NF (as preservative)
Inactive Ingredients: hypromellose, polyethylene glycol, propylene glycol, corn starch
Inactive Ingredient: Purified water.
Description
LOT/EXP: Made in CHINA
20130301
Code No.: GUJ/DRUG/G/1080
Batch No.:
Mfg Date:
Exp: Date:
Made in CHINA
LOT/EXP:
Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755
Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755
Distributed by GENUINE FIRST AID
600 Clevelad Str Suite 400, Clearwater, FL 33755
LOT/EXP: Made in CHINA
20140301
Otc - Ask Doctor
Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic
Ask a doctor before use if the user has liver disease
Ask a doctor before use if: 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, or kidney disease; you are taking a diuretic
Otc - Ask Doctor/Pharmacist
Ask a doctor before use if you are:
taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are:
under a doctor's care for any serious condition; taking any other drug
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
If pregnant or breast-feeding, ask a health professional before use.
If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
General Precautions
tamper evident sealed packets; do not use any open or torn packets
* Please review the disclaimer below.