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

DERMAFIT ATHLETE MUSCLE MAINTENANCE 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82679-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	1.0 g  in 200 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propanediol (UNII: 5965N8W85T)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82679-020-02	1 in 1 CARTON	05/01/2022
1	NDC: 82679-020-01	200 mL in 1 CONTAINER; 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	05/01/2022

Labeler - EX Healthcare Inc. (695315496)

Registrant - EX Healthcare Inc. (695315496)

Establishment
Name	Address	ID/FEI	Business Operations
reBom Co., Ltd.		695951708	manufacture(82679-020)

Revised: 4/2023

Document Id: 9f2fc27c-c1c4-4c41-8e4e-c4d074168c40

34390-5

Set id: 6b3c382a-0ac8-4fc3-89d2-b0d5b9ac0c4b

Version: 2

Effective Time: 20230425