SOUND BODY EXTRA STRENGTH COLD AND HOT- menthol, and methyl salcylate cream 
United Exchange 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.

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Active ingredients                                                                             Purpose

Menthol 10%................................................................................ Topical analgesic

Methyl salcylate 30%..................................................................... Topical analgesic

Uses

temporarily relieves minor pain associated with:

Warnings

For external use only

Allergy alert: if prone to allergic reaction from aspirin or salcylates, consult a doctor before use

When using this product

Stop use and ask a doctor if

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health progessional before use.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 12 years

children 12 years or younger: ask a doctor

Inactive ingredients

isopropyl myristate, lanolin, methylparaben, polysorbate 60, potassium cetyl phosphate, propylparaben, stearic acid, stearyl alcohol, water

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703

MADE IN KOREA

image description

SOUND BODY EXTRA STRENGTH COLD AND HOT 
menthol, and methyl salcylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-616
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-616-351 in 1 CARTON
135.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/24/2015
Labeler - United Exchange Corp. (840130579)

Revised: 2/2015
Document Id: fbbed3fc-3353-4c01-aab2-eee8c7d43cc6
Set id: 098d1cc0-f77b-4c52-94e9-6bbe85f09a5f
Version: 1
Effective Time: 20150224
 
United Exchange Corp.