FDA Label for 4346 First Aid Kit
View Indications, Usage & Precautions
- EYEWASH ACTIVE INGREDIENT
- EYEWASH PURPOSE
- EYEWASHUSES
- EYEWASH WARNINGS
- DO NOT USE
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
- EYEWASH DIRECTIONS
- EYEWASH INACTIVE INGREDIENTS
- EYEWASH QUESTIONS
- TRIPLE ACTIVE INGREDIENTS
- TRIPLE PURPOSE
- TRIPLE USES
- TRIPLE WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- KEEP OUT OF THE REACH OF CHILDREN
- TRIPLE DIRECTIONS
- TRIPLE OTHER INFORMATION
- TRIPLE INACTIVE INGREDIENT
- MIRALAC PURPOSE
- MIRALAC USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- KEEP OUT OF THE REACH OF CHILDREN.
- MIRALAC DIRECTIONS
- MIRALAC OTHER INFORMATION
- MIRALAC INACTIVE INGREDIENTS
- MIRALAC QUESTIONS OR COMMENTS?
- BZK ACTIVE INGREDIENT
- BZK PURPOSE
- BZK USES
- BZK WARNINGS
- BZK DIRECTIONS
- BZK OTHER INFORMATION
- BZK INACTIAVE INGREDIENT
- BZK QUESTIONS
- QUESTIONS OR COMMENTS?
- PAIN STOPPER ACTIVE INGREDIENT (IN EACH TABLET)
- PAIN STOPPER PURPOSE
- PAIN STOPPER USES
- PAIN STOPPER WARNINGS
- ASK A DOCTOR BEFORE USE IF
- STOP USING AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN.
- PAIN STOPPER DIRECTIONS
- PAIN STOPPER OTHER INFORMATION
- PAIN STOPPER INACTIVE INGREDIENTS
- PAIN STOPPER QUESTIONS OR COMMENTS?
- BURN RELIEF WJ ACTIVE INGREDIENT
- BURN RELIEF WJ PURPOSE
- BURN RELIEF WJ USES
- BURN RELIEF WJ WARNINGS
- BURN RELIEF WJ DIRECTIONS
- BURN RELIEF WJ OTHER INFORMATION
- BURN RELIEF WJ INACTIVE INGREDIENTS
- BURN RELIEF WJ QUESTIONS OR COMMENTS?
- 4346 Z68140GRR KIT CONTENTS
- EYEWASH PRINCIPAL DISPLAY PANEL
- TRIPLE PRINCIPAL DISPLAY PANEL
- MIRALAC PRINCIPAL DISPLAY PANEL
- BZK PRINCIPAL DISPLAY PANEL
- PAIN STOPPER PRINCIPAL DISPLAY PANEL
- BURN RELIEFF WJ PRINCIPAL DISPLAY PANEL
- 4346 KIT LABEL Z68140GRR
4346 First Aid Kit Product Label
The following document was submitted to the FDA by the labeler of this product Honeywell Safety Products Usa, Inc. 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.
Eyewash Active Ingredient
Sterile Water 99%
Eyewash Purpose
Eyewash
Eyewashuses
- for flushing the eye to remove loose foreign material, air pollutants or chlorinated water
Eyewash Warnings
For external use only Obtain immediate medical treatment for all open wounds in or near eyes. To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.
Do Not Use
- if solution changes color or becomes cloudy
- if you have open wounds in or near the eyes, get medical help right away.
- in the eyes
- over large areas of the body
- in the eyes or over large areas of the body
- on mucous membranes
- on irritated skin
- in case of deep puncture wounds, animal bites or serious burns, consult a doctor
- longer than 1 week unless directed by a doctor
- 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
- over large areas of the body, particularly over raw surfaces or blistered areas
Stop Use And Ask A Doctor If
- you experience eye pain
- changes in vision
- continued redness or irritation of the eye
- condition worsens or persists
- the condition persists or gets worse
- a rash or other allergic reaction develops
- you need to use longer than 1 week
- if irritation, redness or other symptoms develop
- the condition persists or gets worse
- condition worsens
- symptoms persist for more than 7 days
- condition clears up and occurs again within a few days
Keep Out Of Reach Of Children
- If swallowed, get medical help or contact a Poison Control Center right away.
If swallowed, get medical help or contact a Poison Control Center right away
Eyewash Directions
- remove contacts before using
- twist top to remove
- flush the affected area as needed
- control rate of flow by pressure on the bottle
- if necessary, continue flushing with emergency eyewash or shower
Eyewash Inactive Ingredients
sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic
Eyewash Questions
1-800-430-5490
Triple Active Ingredients
Bacitracin zinc 400 units
Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)
Polymyxin B sulfate 5000 units
Triple Purpose
First aid antibiotic
First aid antibiotic
First aid antibiotic
Triple Uses
- first aid to help prevent infection in
- minor cuts
- scrapes
- burns
Triple Warnings
For external use only
Allergy alert do not use if you are allergic to any of the ingredients
Ask A Doctor Before Use If You Have
- a deep or puncture wounds
- animal bites
- serious burns
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
If swallowed, get medical help or contact a Poison Control Center right away.
Triple Directions
- clean the affected area
- apply a small amount of the 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
Triple Other Information
- store at 15 0 to 25 0 C (59 0 to 77 0 F)
- tamper evident sealed packets
- do not use if packet is torn or opened
Triple Inactive Ingredient
petrolatum
Miralac Purpose
Antacid
Miralac Uses
for the relief of
- acid indigestion
- heartburn
- sour stomach
- upset stomach associated with these symptoms
Warnings
Ask a doctor before use if you have
- kidney stones
- calcium-restricted diet
Ask A Doctor Before Use If You Are
- presently taking a prescription drug. Antacids may interfere with certain prescription drugs
When Using This Product
- do not take more than 12 tablets in a 24- hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.
- avoid contact with the eyes
Keep Out Of The Reach Of Children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Miralac Directions
- chew 1 to 2 tablets every 4 hours as symptoms occur, or as directed by a doctor.
Miralac Other Information
- each tablet contains: calcium 170 mg
- sucrose free
- lactose free
- store at room temperature
- TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN
Miralac Inactive Ingredients
magnesium stearate, mint flavor, silicon dioxide, sorbitol, starch
Miralac Questions Or Comments?
1-800-430-5490
Bzk Active Ingredient
Benzalkonium chloride 0.13% w/v
Bzk Purpose
First aid antiseptic
Bzk Uses
Antiseptic cleansing of face, hands, and body without soap and water
Bzk Warnings
For external use only
Bzk Directions
tear open packet and use as a washcloth
Bzk Other Information
- store at room temperature 15 0 to 30 0 C (5 0 - 86 0 F)
- do not reuse towelette
Bzk Inactiave Ingredient
water
Bzk Questions
1-800-430-5490
Questions Or Comments?
1-800-430-5490
Pain Stopper Active Ingredient (In Each Tablet)
Acetaminophen 110mg
Aspirin 162mg (NSAID)*
Caffeine 32.4mg
Salicylamide 152mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain Stopper Purpose
Pain reliever/fever reducer
Pain reliever/fever reducer
Diuretic
Pain reliever/fever reducer
Pain Stopper Uses
for the temporary relief of minor aches and pains due to:
• common cold
• headache
• muscular aches
• premenstrual and menstrual cramps
Pain Stopper Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or 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
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- blisters
- rash
- more than 12 tablets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
Ask A Doctor Before Use If
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you are taking a diuretic
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
Stop Using And Ask A Doctor If
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pin that does not get better
- if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product.
If Pregnant Or Breast-Feeding
- ask a healthcare professional before use.
It is especially important not 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 pregnancy.
Keep Out Of Reach Of Children.
Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Pain Stopper Directions
- adults and children 12 years of age and over, take 2 tablets every 4 hours while symptoms persist
- do not take more than 12 tablets in 24 hours
- children under 12 years: consult a doctor
Pain Stopper Other Information
- store at a controlled room temperature 15 0 -30 0 C (59 0 -86 0 F)
- TAMPER EVIDENT-DO NOT USE IF OPEN OR TORN
Pain Stopper Inactive Ingredients
FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch, stearic acid,
Pain Stopper Questions Or Comments?
1-800-430-5490
Burn Relief Wj Active Ingredient
Lidocaine HCl 2%
Burn Relief Wj Purpose
External analgesic
Burn Relief Wj Uses
- temporarily relieves pain due to minor burns
Burn Relief Wj Warnings
For external use only
Burn Relief Wj Directions
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: ask a doctor
Burn Relief Wj Other Information
- store at room temperature
Burn Relief Wj Inactive Ingredients
diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, purified water, tea tree oil, trolamine
Burn Relief Wj Questions Or Comments?
1-800-430-5490
4346 Z68140grr Kit Contents
1 1X3 PLASTIC 100/BOX
1 WOVEN 7/8 X 3 50/BOX
1 SWIFT KNUCKLE 40/BX
1 SWIFT FINGERTIP 8 50/BOX
2 TRIPLE ANTIBIOTIC 10 PER
1 EYE DRESS PKT W/4 ADH STRIPS
1 INSTANT COLD PACK 4" X 6"
1 ADHESIVE TAPE W/P 1/2"X 5 YD
1 TWEEZER PLASTICS 4"
1 O/H PUMP BURN RELIEF 2 OZ ID G
1 BLOODSTOPPER
1 NON-ADHERENT PADS 2"X3" 10'S
1 GZE PADS STERILE 3"X 3" 25'S
2 ANTISEPTIC WIPES BZK CHL 20'S
1 PAIN STOPPERS IND PK 2ENV 100
1 MIRALAC TABS IND PK 2/ENV 100
1 4OZ BFS EYEWASH TRILINGUAL BOTTLE
1 F A KIT EMPTY BLANK 140
1 POCKET INSERT RED #140 KIT 2R
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
2 PR LRG NITRILE GLVES ZIP BAG
1 TRI BNDG NON WOVEN 40"X40"X56"
Eyewash Principal Display Panel
Triple Principal Display Panel
Miralac Principal Display Panel
4346 Kit Label Z68140grr
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