Neosporin Plus Pain Relief Cream
FDA Label NDC 69968-0055

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Neosporin Plus Pain Relief (NDC 69968-0055). 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 other, active ingredient (in each caplet), purpose, uses, liver warning, do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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
        • first aid to help prevent infection and for the temporary relief of pain in minor:

          • cuts
          • scrapes
          • burns

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
  • These could be signs of a serious condition.

    • 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

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)
  • adults and children 12 years and over
    • 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
    children under 12 yearsask 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

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 starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch, polyethylene glycol, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

cetyl 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 ingredientsPurpose
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

Principal Display Panel (Kit Package Label)

Principal Display Panel (Kit Package Label)

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