CVS COLD HOT MEDICATED- menthol patch

CVS Cold Hot Medicated by

Drug Labeling and Warnings

CVS Cold Hot Medicated by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient                                                    Purpose

Menthol 5% .......................................................Topical Analgesic

PURPOSE

Uses

Temporarily relieves minor pain associated with:

• Arthritis
• Simple Backache
• Bursitis
• Tendonitis
• Muscle Strains
• Bruises
• Cramps

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
• Do not apply to wounds or damaged 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 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. If swallowed, get medical help or contact a Poision 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 under 12 years of age consult a doctor

STORAGE AND HANDLING

Other Information

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

INACTIVE INGREDIENT

Inactive Ingredients:

1,3 butylene glycol, aloe vera (powder), dibutylhydroxytoluene, disodium edetate, d-sorbital solution, glycerine, kaolin, light liquid paraffin, magnesium aluminum hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium methaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

CVS PHARMACY, INC.

ONE CVS DRIVE

WOONSOCKET, RI 02895 USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS COLD HOT MEDICATED 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-821
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
PARAFFIN (UNII: I9O0E3H2ZE)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-821-05	5 in 1 BOX
1		.05 g in 1 PATCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/14/2013

Labeler - CVS Pharmacy Inc. (062312574)