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

Sound Body Extra Strength Cold and Hot by

Drug Labeling and Warnings

Sound Body Extra Strength Cold and Hot by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                             Purpose

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

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

PURPOSE

Uses

temporarily relieves minor pain associated with:

• arthritis
• simple backache
• muscle strains
• sprains
• bruises
• cramps

WARNINGS

Warnings

For external use only

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

WHEN USING

When using this product

• use only as directed
• do not bandage tightly or use with a heating pad
• avoid contact with eyes or mucous membranes
• do not apply to wounds, damaged, broken or irritated skin

STOP USE

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again wtihin a few days
• redness is present
• irritation develops

ASK DOCTOR

Stop use and ask a doctor if

• condition worsens
• symptoms perist for more than 7 days or clear up and occur again within a few days
• redness is present
• irritation develops

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Directions

adults and children over 12 years

• apply generously to affected area
• massage into painful area until thoroughly absorbed into skin
• repeat as necessary, but no more than 4 times daily
• close cap tightly after use
• keep carton as it contains important information

children 12 years or younger: ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOUND BODY EXTRA STRENGTH COLD AND HOT 
menthol, and methyl salcylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-616
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-616-35	1 in 1 CARTON
1		35.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/24/2015

Labeler - United Exchange Corp. (840130579)