PAIN RELIEF RUB IAMPUR- camphor, menthol, methyl salicylate cream 
Avaria Health & Beauty Corp

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.

----------

Avaria Pain Relief Rub

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

Uses

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

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. 

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 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

Topical Analgesic.


Keep out of reach of children.

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

label2

PAIN RELIEF RUB  IAMPUR
camphor, menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43493-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 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 SALICYLATE11 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43493-0001-1198 g in 1 TUBE; Type 0: Not a Combination Product10/30/2017
2NDC:43493-0001-256 g in 1 TUBE; Type 0: Not a Combination Product10/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/30/2017
Labeler - Avaria Health & Beauty Corp (248926979)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(43493-0001)

Revised: 11/2017
Document Id: 5e077cb6-5443-00fd-e053-2a91aa0a1e69
Set id: b3ea7ebc-86e2-48d7-b629-8ccb2d312c6b
Version: 8
Effective Time: 20171115
 
Avaria Health & Beauty Corp