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

Drug Details [pdf]

DERMAFIT BASIC 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 0.2%

INACTIVE INGREDIENTS

Water, Propanediol, Glycerin, Butylene Glycol, Cetyl Ethylhexanoate, 1,2-Hexanediol, Camellia Japonica Flower Extract, 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 BASIC MUSCLE MAINTENANCE
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82679-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	0.4 g in 200 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 82679-010-02	1 in 1 CARTON	05/01/2022
1	NDC: 82679-010-01	200 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/01/2022

Labeler - EX Healthcare Inc. (695315496)

Registrant - EX Healthcare Inc. (695315496)

Name	Address	ID/FEI	Business Operations
Establishment
reBom Co., Ltd.		695951708	manufacture(82679-010)

Revised: 4/2023

Document Id: a72db80d-7e6d-4d8c-8cfa-43ddab8cee31

Set id: 9a341bb0-db8e-4100-a609-45dfc4ffce6a

Version: 2

Effective Time: 20230425