TOTAL MUSCLE RELIEF- menthol, camphor gel

TOTAL MUSCLE RELIEF by

Drug Labeling and Warnings

TOTAL MUSCLE RELIEF by is a Otc medication manufactured, distributed, or labeled by Electrostim Medical Services Inc. d/b/a EMSI, DIVERSIFIED MANUFACTURING CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol ---5.0%

PURPOSE

Cooling Pain Relief

USES

Temporary relief from minor aches and pains of sore muscles and joints associated with arthrilis backaches strains sprains

WARNINGS

FOR EXTERNAL USE ONLY.

FLAMMABLE; KEEP AWAY FROM EXCESSIVE HEAT OR OPEN FLAME.

Ask doctor before use if you have: Sensitive skin. When using this product: Avoid contact with the eyes or mucus membranes. Do not apply to wounds or damaged skin. Do not use with other ointments, creams, sprays or liniments. Do not apply to irritated skin of if excessive irritation develpes. Do not bandage. Wash hand after use with cold water. Do not use heating pads or device. Store in a cool dry place.

Stop use and ask doctor if: condition worsens or if symptoms percist for more than 7 days or clear up and recur.

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: if accidently ingested get medical help or contact Poison Control Center immediately.

DIRECTIONS

ADULT AND CHILDREN 2 YEARS OF AGE AND OLDER: RUB A THIN FILM OVER AFFECTED AREAS NOT MORE THAN 4 TIMES DAILY. MASSAGE NOT NECESSARY.

CHILDREN UNDER 2 YEARS OF AGE: CONSULT PHYSICIAN.

INACTIVE INGREDIENTS

PURIFIED WATER, Extract of Aloe Vera, Witch Hazel, Water Cress and Rosemary, Isopropanol, Glycerin, Coconut Oil, Sweet Almond Oil, Emu Oil, Carbomer, Sodium Hydroxide, Silica, F. D. & C Yellow #5, F. D.& C Blue #1, DMDM Hydantoin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOTAL MUSCLE RELIEF 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50130-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WITCH HAZEL (UNII: 101I4J0U34)
WATERCRESS (UNII: K5877MW0LE)
ROSEMARY (UNII: IJ67X351P9)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT OIL (UNII: Q9L0O73W7L)
ALMOND OIL (UNII: 66YXD4DKO9)
EMU OIL (UNII: 344821WD61)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50130-108-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/16/2019
2	NDC: 50130-108-13	89 mL in 1 TUBE; Type 0: Not a Combination Product	02/16/2019
3	NDC: 50130-108-23	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	02/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/16/2019

Labeler - Electrostim Medical Services Inc. d/b/a EMSI (932471881)

Establishment
Name	Address	ID/FEI	Business Operations
DIVERSIFIED MANUFACTURING CORP		185073996	manufacture(50130-108)