CVS EXTRA STRENGTH COLD AND HOT MEDICATED- menthol patch 
Bershtel Enterprises

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient Purpose

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

Temporarily relieves minor pain associated with:

arthritis
simple backache
bursitis
tendonitis
muscle strains
muscle sprains
bruises
cramps

Temporarily relieves minor pain associated with:

arthritis
simple backache
bursitis
tendonitis
muscle strains
muscle sprains
bruises
cramps

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Other information

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

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 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

product carton

CVS EXTRA STRENGTH COLD AND HOT MEDICATED 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10564-4260
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL750 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10564-4260-51 in 1 CARTON; Type 0: Not a Combination Product09/20/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/20/201301/05/2021
Labeler - Bershtel Enterprises (066659129)

Revised: 1/2021
 
Bershtel Enterprises