ORIGINAL PAIN-A-TRATE PAIN-RELIEVING CREAM- camphor and menthol and methyl salicylate cream

Original Pain-A-Trate by

Drug Labeling and Warnings

Original Pain-A-Trate by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc., Melaleuca, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Camphor 3.25%

Menthol, 1.5%

Methyl Salicylate, 15%

PURPOSE

Purpose

Topical analgesic

INDICATIONS & 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.

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

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

ASK DOCTOR

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

WHEN USING

When using this product

• avoid contact with eyes or mucus membranes
• do not bandage tightly
  

STOP USE

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
  

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORIGINAL PAIN-A-TRATE  PAIN-RELIEVING CREAM
camphor and menthol and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-335
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	32.5 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	15 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TEA TREE OIL (UNII: VIF565UC2G)
COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CORALLINA OFFICINALIS (UNII: 4004498D06)
CURCUMA LONGA WHOLE (UNII: W5488JUO8U)
OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)
OCIMUM GRATISSIMUM LEAF OIL (UNII: AVG2506KDV)
TROLAMINE (UNII: 9O3K93S3TK)
SODIUM COPPER CHLOROPHYLLIN A (UNII: VAC44EX123)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
SOLANUM MELONGENA WHOLE (UNII: 5DS5EE0N93)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-335-03	85 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/01/2021

Labeler - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc		079711683	manufacture(54473-335)