Pain-a-trate Extra Strength Pain-relieving Cream

Drug Facts

Composition & Product

Active Ingredients

Camphor (synthetic) (32.5 mg) Menthol (15 mg) Salicylic Acid (150 mg)

Inactive Ingredients

Water Glyceryl Monostearate Stearic Acid Cetyl Alcohol Sorbitan Monostearate Polysorbate 20 Tea Tree Oil Trolamine Carbomer Copolymer Type B Benzyl Alcohol Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2007-05-01

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses for the temporary relief of minor aches and pains of muscles and joints. Provides penetrating pain relief of aches and pains associated with:

simple backache
arthritis
strains
bruises
sprains

Dosage and Administration

Directions

apply generously to affected area with gentle massage
do not apply more than 3 to 4 times daily

Description

Active ingredients Camphor 3.25% Menthol, 1.5% Methyl Salicylate, 15%

Section 44425-7

Other information do not store above 95°F (35°C)

Section 50565-1

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days
excessive skin irritation occurs

Section 50567-7

When using this product

avoid contact with eyes or mucus membranes
do not bandage tightly

Section 50569-3

Ask a doctor before use if you have redness over the affected area.

Section 50570-1

Do not use

on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions

Section 51727-6

Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, benzyl alcohol, cetyl alcohol, deionized water, FD and C blue no. 1, FD and C yellow no. 5, glyceryl monostearate SE, Melaleuca Oil (T36-C5 ^® brand), polysorbate 20, sorbitan stearate, steric acid, triethanolamine

Section 51945-4

Section 55105-1

Purpose

Topical analgesic

Section 55106-9

Active ingredients

Camphor 3.25%

Menthol, 1.5%

Methyl Salicylate, 15%

Structured Label Content

Indications and Usage (34067-9)

Uses for the temporary relief of minor aches and pains of muscles and joints. Provides penetrating pain relief of aches and pains associated with:

simple backache
arthritis
strains
bruises
sprains

Dosage and Administration (34068-7)

Directions

apply generously to affected area with gentle massage
do not apply more than 3 to 4 times daily

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information do not store above 95°F (35°C)

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days
excessive skin irritation occurs

Section 50567-7 (50567-7)

When using this product

avoid contact with eyes or mucus membranes
do not bandage tightly

Section 50569-3 (50569-3)

Ask a doctor before use if you have redness over the affected area.

Section 50570-1 (50570-1)

Do not use

on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions

Section 51727-6 (51727-6)

Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, benzyl alcohol, cetyl alcohol, deionized water, FD and C blue no. 1, FD and C yellow no. 5, glyceryl monostearate SE, Melaleuca Oil (T36-C5 ^® brand), polysorbate 20, sorbitan stearate, steric acid, triethanolamine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Topical analgesic

Section 55106-9 (55106-9)

Active ingredients

Camphor 3.25%

Menthol, 1.5%

Methyl Salicylate, 15%

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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