FDA Label for Neosporin Plus Pain Relief First Aid Antibiotic/pain Relieving
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USES
- LIVER WARNING
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- OTC - PURPOSE
- WARNINGS
- ASK A DOCTOR BEFORE USE
- OTC - WHEN USING
- QUESTIONS?
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- PRINCIPAL DISPLAY PANEL - KIT PACKAGE LABEL
Neosporin Plus Pain Relief First Aid Antibiotic/pain Relieving Product Label
The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer 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.
Other
Drug Facts
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Drug Facts
Drug Facts
Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558
Active Ingredient (In Each Caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
- temporarily relieves pain and itching associated with:
- insect bites
- minor burns
- sunburn
- minor skin irritations
- minor cuts
- scrapes
- rashes due to poison ivy, poison oak, and poison sumac
- dries the oozing and weeping of poison ivy, poison oak, and poison sumac
- cuts
- scrapes
- burns
first aid to help prevent infection and for the temporary relief of pain in minor:
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- on large areas of the body
- with any other product containing diphenhydramine, even one taken by mouth
- if you are allergic to any of the ingredients
- in the eyes
- over large areas of the body
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
- condition worsens or does not improve within 7 days
- symptoms persist for more than 7 days or clear up and occur again within a few days
- you need to use longer than 1 week
- condition persists or gets worse
- symptoms persist for more than 1 week, or clear up and occur again within a few days
- rash or other allergic reaction develops
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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 Centre right away.
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
- do not use more than directed
- 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
- adults and children 2 years of age and older:
- 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
- children under 2 years of age: ask a doctor
adults and children 12 years and over | |
children under 12 years | ask a doctor |
Other Information
- store between 20-25°C (68-77°F)
- do not use if pouch is torn or damaged
- protect from excessive heat (40°C/104°F)
- store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
carnauba wax
contains one or more of these ingredients
, corn starchcetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water
Water, Emulsifying Wax, Mineral Oil, Petrolatum, Propylene Glycol, Methylparaben, Sulfuric acid, Sodium Hydroxide
Questions Or Comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Otc - Purpose
Active ingredients | Purpose |
---|---|
Diphenhydramine hydrochloride 2% | Topical analgesic |
Zinc acetate 0.1% | Skin protectant |
Active ingredients (in each gram) | Purpose |
---|---|
Neomycin Sulfate (3.5 mg) | First aid antibiotic |
Polymyxin B Sulfate (10,000 units) | First aid antibiotic |
Pramoxine HCl (10 mg) | External analgesic |
Warnings
For external use only
For external use only.
Ask A Doctor Before Use
- on chicken pox
- on measles
Otc - When Using
When using this product avoid contact with eyes
Questions?
call toll-free 800-524-2624 (English/Spanish) or 215-273-8755 (collect)
call 800-223-0182 or 215-273-8755 (collect)
Ask A Doctor Before Use If You Have
- deep or puncture wounds
- animal bites
- serious burns
Principal Display Panel - Kit Package Label
Johnson & Johnson®
ALL-PURPOSE
FIRST AID KIT
OUTDOORS
ON-THE-GO
AT HOME
INCLUDES
$20
VALUE
5 FULL-SIZE ITEMS
CUTS & SCRAPES
MINOR BURNS
ITCH RELIEF
PAIN RELIEF
SKIN RASHES
INSECT BITES
140 ITEMS
SEE BACK PANEL
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