Original Pain-a-trate Pain-relieving Cream

Original Pain-a-trate Pain-relieving Cream
SPL v4
SPL
SPL Set ID cf6daad3-204e-aff3-e053-2995a90adb94
Route
TOPICAL
Published
Effective Date 2021-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (32.5 mg) Menthol (15 mg) Salicylic Acid (150 mg)
Inactive Ingredients
Azadirachta Indica Flower Glyceryl Stearate Se Water Stearic Acid Cetyl Alcohol Sorbitan Monostearate Polysorbate 20 Tea Tree Oil Coccinia Grandis Fruit Ethylhexylglycerin Benzyl Alcohol Corallina Officinalis Curcuma Longa Whole Ocimum Basilicum Flowering Top Ocimum Gratissimum Leaf Oil Trolamine Sodium Copper Chlorophyllin A Azadirachta Indica Leaf Solanum Melongena Whole Aloe Vera Flower Carbomer Interpolymer Type A (allyl Sucrose Crosslinked)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-01
Description

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

Medication Information

Warnings and Precautions

Warnings



For external use only

Indications and Usage

Indications For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains. Provides penetrating pain relief.

Dosage and Administration

Directions

  • apply 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
  • symptoms clear up and occur again within a few 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, aloe barbadensis flower extract, benzyl alcohol, cetyl alcohol, chlorophyllin-copper complex, coccinia indica fruit extract, corallina officianalis extract, curcuma longa (turmeric) root extract, ethylhexylglyverin, glyceryl monostearate SE, melaleuca alternifolia (tea tree) leaf oil, melia azadirachta flower extract, melia azadirachta leaf extract, ocimum basilicum (basil) flower/leaf extract, ocimum sanctum (holy basil) leaf extract, polysorbate 20, solanum melongena (eggplant) fruit extract, sorbitan stearate, stearic acid, triethanolamine, water

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)

Indications For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains. Provides penetrating pain relief.

Dosage and Administration (34068-7)

Directions

  • apply 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
  • symptoms clear up and occur again within a few 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, aloe barbadensis flower extract, benzyl alcohol, cetyl alcohol, chlorophyllin-copper complex, coccinia indica fruit extract, corallina officianalis extract, curcuma longa (turmeric) root extract, ethylhexylglyverin, glyceryl monostearate SE, melaleuca alternifolia (tea tree) leaf oil, melia azadirachta flower extract, melia azadirachta leaf extract, ocimum basilicum (basil) flower/leaf extract, ocimum sanctum (holy basil) leaf extract, polysorbate 20, solanum melongena (eggplant) fruit extract, sorbitan stearate, stearic acid, triethanolamine, water

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:02.272228 · Updated: 2026-03-14T23:12:10.193103