SOUND BODY EXTRA STRENGTH COLD AND HOT MEDICATED- menthol patch

Sound Body Extra Strength Cold and Hot Medicated by

Drug Labeling and Warnings

Sound Body Extra Strength Cold and Hot Medicated 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 ingredeint                                                                           Purpose

Menthol 5%.............................................................................. Topical analgesic

PURPOSE

Uses

Temporarily relieves minor pain associated with:

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

WARNINGS

Warnings

For external use only

WHEN USING

When using this product

• use only as directed
• do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes
• redness is present
• skin irritation develops

ASK DOCTOR

Stop use and ask a doctor if

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional 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 12 years of age and older

• peel off protective backing and apply sticky side to affected area
• carefully remove backing from patch
• should be used up to 8 hours
• should be used no more than 3 times a day
• children 12 years of younger: ask a doctor

STORAGE AND HANDLING

Other information

• store at room temperature, not to exceed 86°F (30°C)

INACTIVE INGREDIENT

Inactive ingredients

aluminum hydroxide, camphor, eucalyptus oil, glycerine, methylparaben, polyacrylic acid, propaneidol, propylparaben, purified water

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703

MADE IN CHINA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOUND BODY EXTRA STRENGTH COLD AND HOT MEDICATED 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-621
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-621-01	1 in 1 POUCH
1		1 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/25/2015

Labeler - United Exchange Corp. (840130579)