PAIN RELIEF RUB IAMPUR- camphor, menthol, methyl salicylate cream

Pain Relief Rub by

Drug Labeling and Warnings

Pain Relief Rub by is a Otc medication manufactured, distributed, or labeled by Avaria Health & Beauty Corp, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Camphor 4%, Menthol 4%, Methyl Salicylate 11%

INDICATIONS & USAGE

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, back ache, strains, bruises, and sprains.

WARNINGS

Warnings

For external use only. Use only as directed.  Consult your doctor before use if you have allergies to aspirin or salicylate.  Avoid contact with eyes and mucous membranes.  If contact occurs, flush with water for 15 minutes.  Do not apply to wounds or damaged skin.  If pain persists for more than 7 days or becomes worse consult a physician.  Children under 12 years of age should consult a physician before use. 

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years of age and older:  use no more than 3 to 4 times daily.  Apply cream to affected  areas and thoroughly massage until penetrated.  Wash hands with soap and water after use.

INACTIVE INGREDIENT

Inactive ingredients

Arnica Montana, Carbomer, Cetearyl Alcohol, Ceteth-10 Phosphate, Dicetyl Phosphate, Glycerin, Isopropyl Palmitate, Methylsulfonylmethane (MSM), Oryza sativa (Rice) Bran Oil, Phenoxyethanol, Purified Water, Sodium Hydroxide

PURPOSE

Purpose

Topical Analgesic.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF RUB  IAMPUR
camphor, menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43493-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	4 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	11 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
RICE BRAN OIL (UNII: LZO6K1506A)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43493-0001-1	198 g in 1 TUBE; Type 0: Not a Combination Product	10/30/2017
2	NDC: 43493-0001-2	56 g in 1 TUBE; Type 0: Not a Combination Product	10/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/30/2017

Labeler - Avaria Health & Beauty Corp (248926979)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(43493-0001)