CVS EXTRA STRENGTH COLD AND HOT MEDICATED- menthol patch

Cvs Extra Strength Cold And Hot Medicated by

Drug Labeling and Warnings

Cvs Extra Strength Cold And Hot Medicated by is a Otc medication manufactured, distributed, or labeled by Bershtel Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

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

INDICATIONS & USAGE

Temporarily relieves minor pain associated with:

arthritis
simple backache
bursitis
tendonitis
muscle strains
muscle sprains
bruises
cramps

PURPOSE

Temporarily relieves minor pain associated with:

arthritis
simple backache
bursitis
tendonitis
muscle strains
muscle sprains
bruises
cramps

ASK DOCTOR

Stop use and ask a doctor if

if condition worsens
symptoms persists 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 Poison Control Center right away.

DOSAGE & ADMINISTRATION

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°F (30°C)

WARNINGS

Warnings

For external use only

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

INACTIVE INGREDIENT

Inactive ingredients 1,3-butylene glycol, aloe vera, butylated hydroxytoluene, edetate disodium, gelatin, glycerin, kaolin, magnesium aluminum hydroxide, metacrylic acid butylacrylate copolymer, methylparaben, mineral oil, polysorbate 80, purified water, sodium methaphosphate, sodium polyacrylate, sorbitan monooleate, sorbitol, tartaric acid, titanium dioxide, tocopherol acetate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS EXTRA STRENGTH COLD AND HOT MEDICATED 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10564-4260
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
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
KAOLIN (UNII: 24H4NWX5CO)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
SORBITOL (UNII: 506T60A25R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10564-4260-5	1 in 1 CARTON; Type 0: Not a Combination Product	09/20/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/20/2013

Labeler - Bershtel Enterprises (066659129)