TOTAL MUSCLE RELIEF- menthol, camphor spray

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 ---10.5%

Purpose

Cooling Pain Relief

USES

Temporary relief from minor aches and pains of sore muscles and joints associated with arthrilis backaches strains and 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 develops. 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 persist 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 12 years of age and older: Spray on to the affected areas not more than four times daily. Massage not necessary.
Children under 12 years of age: Consult physician.

Inactive ingredients

Purified water, Extract of Aloe Vera, Witch Hazel, Water Cress and Rosemary, Isopropanol, Glycerin, Polysorbate 20, Coconut Oil, Sweet Almond Oil, Emu Oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOTAL MUSCLE RELIEF 
menthol, camphor spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50130-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10.5 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)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
COCONUT OIL (UNII: Q9L0O73W7L)
ALMOND OIL (UNII: 66YXD4DKO9)
EMU OIL (UNII: 344821WD61)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50130-109-14	118 mL in 1 BOTTLE, SPRAY; 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(50130-109)