ORIGINAL PAIN-A-TRATE PAIN-RELIEVING CREAM- camphor and menthol and methyl salicylate cream 
Melaleuca, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Original Pain-A-Trate Pain-Relieving Cream

Active ingredients

Camphor 3.25%

Menthol, 1.5%

Methyl Salicylate, 15%

Purpose

Topical analgesic

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

For external use only

Do not use

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

When using this product

Stop use and ask a doctor if

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

Directions

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

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

Pain-A-Trate Original Tube 3oz

ORIGINAL PAIN-A-TRATE  PAIN-RELIEVING CREAM
camphor and menthol and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-335
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)32.5 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-335-0385 g in 1 TUBE; Type 0: Not a Combination Product10/01/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2021
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc079711683manufacture(54473-335)

Revised: 1/2023
Document Id: f205b4ae-b264-34d9-e053-2a95a90a7f19
Set id: cf6daad3-204e-aff3-e053-2995a90adb94
Version: 2
Effective Time: 20230111
 
Melaleuca, Inc.