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

Ultra Pain-A-Trate by

Drug Labeling and Warnings

Ultra 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 4%

Menthol 10%

Methyl Salicylate 30%

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, and sprains. Provides penetrating 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, benzyl alcohol, deionized water, glyceryl monostearate SE, melaleuca alternifolia (tea tree) leaf oil, polysorbate 80, propanediol, steareth-2, steareth-21, stearic acid, triethanolamine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-334
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.4 g  in 85 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8.5 g  in 85 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	25.5 g  in 85 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-334-03	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 Drug	505G(a)(3)	10/01/2021

Labeler - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc		079711683	manufacture(54473-334)