PAIN-A-TRATE EXTRA STRENGTH PAIN-RELIEVING- camphor and menthol and methyl salicylate cream

Pain-A-Trate by

Drug Labeling and Warnings

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

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
  

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
• 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 generously 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, 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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN-A-TRATE  EXTRA STRENGTH PAIN-RELIEVING
camphor and menthol and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-150
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
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TEA TREE OIL (UNII: VIF565UC2G)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER COPOLYMER TYPE B (UNII: 1G56KV7BUJ)
BENZYL ALCOHOL (UNII: LKG8494WBH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-150-03	85 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018
2	NDC: 54473-150-01	28 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2007

Labeler - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc		079711683	manufacture(54473-150)