TOTAL MUSCLE RELIEF- menthol, camphor spray 
Electrostim Medical Services Inc. d/b/a EMSI

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 ---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: 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

TOTAL MUSCLE RELIEF 4oz spray v1.1

TOTAL MUSCLE RELIEF 
menthol, camphor spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50130-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50130-109-14118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/16/2019
Labeler - Electrostim Medical Services Inc. d/b/a EMSI (932471881)
Establishment
NameAddressID/FEIBusiness Operations
DIVERSIFIED MANUFACTURING CORP185073996manufacture(50130-109)

Revised: 2/2019
Document Id: 8177a68a-892c-4bfa-8de8-d2d886bd5569
Set id: b6f8e297-75a0-4984-b2aa-5ab7d947654b
Version: 1
Effective Time: 20190216
 
Electrostim Medical Services Inc. d/b/a EMSI