Johnson And Johnson First Aid Kit All Purpose 160 Ct

Johnson And Johnson First Aid Kit All Purpose 160 Ct
SPL v3
SPL
SPL Set ID f3933330-2550-4a88-e053-2a95a90a3997
Routes
ORAL TOPICAL
Published
Effective Date 2023-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (20 mg) Zinc Cation (1 mg) Neomycin (3.5 mg) Polymyxin B (10000 [USP'U]) Pramoxine (10 mg)
Inactive Ingredients
Carnauba Wax Starch, Corn Fd&c Red No. 40 Aluminum Oxide Hypromellose, Unspecified Magnesium Stearate Polyethylene Glycol, Unspecified Powdered Cellulose Propylene Glycol Shellac Sodium Starch Glycolate Type A Titanium Dioxide Cetyl Alcohol Diazolidinyl Urea Methylparaben Propylparaben Water Mineral Oil Petrolatum Sulfuric Acid Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Imprint: TYLENOL;500 Shape: oval Color: white Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-31

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product avoid contact with eyes

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you have liver disease

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients Purpose
Diphenhydramine HCL 2% Topical analgesic
Zinc acetate 0.1% Skin protectant
Warnings

For external use only

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 years ask a doctor
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
Questions?

call toll-free 800-524-2624 (English/Spanish) or 215-273-8755 (collect)

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
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.

Other Information
  • store between 20-25°C (68-77°F)
  • do not use if pouch is torn or damaged
Inactive Ingredients

carnauba wax*, 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

*contains one or more of these ingredients

Questions Or Comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Ask A Doctor Before Use
  • on chicken pox
  • on measles
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.

Active Ingredient (in Each Caplet)

Acetaminophen 500 mg

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

NEW

160

PIECES

$27 VALUE WITH

REFILLABLE CASE


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients Purpose
Diphenhydramine HCL 2% Topical analgesic
Zinc acetate 0.1% Skin protectant
Purpose

Pain reliever/fever reducer

Warnings

For external use only

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 years ask a doctor
Do Not Use (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
Questions?

call toll-free 800-524-2624 (English/Spanish) or 215-273-8755 (collect)

Liver Warning (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
Overdose Warning (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.

Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • do not use if pouch is torn or damaged
Inactive Ingredients (Inactive ingredients)

carnauba wax*, 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

*contains one or more of these ingredients

Questions Or Comments? (Questions or comments?)

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Ask A Doctor Before Use (Ask a doctor before use)
  • on chicken pox
  • on measles
Stop Use and Ask A Doctor If (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.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen 500 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns
Principal Display Panel Kit Package Label (PRINCIPAL DISPLAY PANEL - Kit Package Label)

Johnson & Johnson ®

ALL-PURPOSE

FIRST AID KIT

NEW

160

PIECES

$27 VALUE WITH

REFILLABLE CASE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)