CVS COLD AND HOT MEDICATED XL- menthol patch

CVS COLD AND HOT MEDICATED XL by

Drug Labeling and Warnings

CVS COLD AND HOT MEDICATED XL by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                               Purpose

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

PURPOSE

Uses temporarily relieves minor pain associated with:

• arthritis
• simple backache
• bursitis
• tendonitis
• muscle strains
• muscle 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 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
• redness is present
• skin irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days

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.  Do not use on infants.  If swallowed, get medical help or contact a Poison Control Center immediately

INDICATIONS & USAGE

Directions

adults and children over 12 years:

• 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:

consult a doctor

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

aloe barbadensis leaf juice, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kanolin, magnesium aluminate metasilicate, methylparaben, peg-40 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

release liner: polyethylene, non-woven material: polyester non-woven fabric.

DOSAGE & ADMINISTRATION

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

www.cvs.com               1-800-shop-CVS

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS COLD AND HOT MEDICATED XL 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-981
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	750 mg

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CASTOR OIL (UNII: D5340Y2I9G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-40 STEARATE (UNII: ECU18C66Q7)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL (UNII: 532B59J990)
WATER (UNII: 059QF0KO0R)
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: 59779-981-04	1 in 1 CARTON	11/11/2010
1		3 in 1 POUCH; 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	11/11/2010

Labeler - CVS PHARMACY, INC. (062312574)

Registrant - UNITED EXCHANGE CORP. (840130579)

Establishment
Name	Address	ID/FEI	Business Operations
SINSIN PHARMACEUTICAL CO., LTD.		687867143	manufacture(59779-981)