ULTRA 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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Ultra Pain-A-Trate Pain-Relieving Cream

Active ingredients

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Purpose

Topical analgesic

Indications For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Provides penetrating 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, benzyl alcohol, deionized water, glyceryl monostearate SE, melaleuca alternifolia (tea tree) leaf oil, polysorbate 80, propanediol, steareth-2, steareth-21, stearic acid, triethanolamine

Tube

ULTRA PAIN-A-TRATE  PAIN-RELIEVING CREAM
camphor and menthol and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-334
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.4 g  in 85 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8.5 g  in 85 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE25.5 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
PROPANEDIOL (UNII: 5965N8W85T)  
STEARETH-2 (UNII: V56DFE46J5)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TEA TREE OIL (UNII: VIF565UC2G)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STEARETH-21 (UNII: 53J3F32P58)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-334-0385 g in 1 TUBE; Type 0: Not a Combination Product10/01/2021
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(54473-334)

Revised: 1/2023
Document Id: f383eeef-f80a-8ea4-e053-2995a90a514c
Set id: cf48b8ca-651d-20d4-e053-2a95a90a4310
Version: 2
Effective Time: 20230130
 
Melaleuca, Inc.