dermaFIT Athlete Muscle Maintenance by EX Healthcare Inc. / reBom Co., Ltd.

dermaFIT Athlete Muscle Maintenance by

Drug Labeling and Warnings

dermaFIT Athlete Muscle Maintenance by is a Otc medication manufactured, distributed, or labeled by EX Healthcare Inc., reBom Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DERMAFIT ATHLETE MUSCLE MAINTENANCE- menthol cream 
EX Healthcare Inc.

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

Menthol 0.5%

INACTIVE INGREDIENTS

Water, Propanediol, Glycerin, Butylene Glycol, Cetyl Ethylhexanoate, Camellia Japonica Flower Extract, 1,2-Hexanediol, Sorbitan Olivate, Cetearyl Glucoside, Cetearyl Olivate, Betaine, Arginine, Sodium Hyaluronate, Carbomer, Silica, Ethylhexylglycerin, Cetearyl Alcohol

PURPOSE

Topical Analgesic

WARNINGS

■ For external use only.
■ When using this product ∙ avoid contact with eyes and mucous membranes ∙ do not apply to wounds or damaged skin ∙ do not bandage tightly or use with a heating pad
■ Stop use and ask doctor if ∙ condition worsens ∙ symptoms persist for more than 7 days or clear up and occur again within a few days
■ Keep out of reach of children. If swallowed, get medical help or contact a Poison control Center immediately.
■ 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 immediately.

Uses

■ For the temporary relief of minor aches and pains of muscles and joints associated with: ∙simple backache ∙ arthritis ∙ strains ∙ bruises ∙ sprains

Directions

■ adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.
■ children under1 2 years of age: consult a doctor.

Other Information

■ Store at room temperature.

QUESTIONS

■ +82-70-7954-9911 or exhealthcare.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

DERMAFIT ATHLETE MUSCLE MAINTENANCE 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82679-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol1.0 g  in 200 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propanediol (UNII: 5965N8W85T)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82679-020-021 in 1 CARTON05/01/2022
1NDC: 82679-020-01200 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2022
Labeler - EX Healthcare Inc. (695315496)
Registrant - EX Healthcare Inc. (695315496)
Establishment
NameAddressID/FEIBusiness Operations
reBom Co., Ltd.695951708manufacture(82679-020)

Revised: 4/2023
 

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