TOTAL MUSCLE RELIEF- menthol, camphor gel 
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 ---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: 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

TOTAL MUSCLE RELIEF 3oz Roll On

TOTAL MUSCLE RELIEF 4oz tube

TOTAL MUSCLE RELIEF 16oz

TOTAL MUSCLE RELIEF 
menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50130-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.0 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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50130-108-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/16/2019
2NDC:50130-108-1389 mL in 1 TUBE; Type 0: Not a Combination Product02/16/2019
3NDC:50130-108-2389 mL in 1 BOTTLE, WITH APPLICATOR; 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(50130-108)

Revised: 2/2019
Document Id: c5248e38-1fa5-4fba-85f8-af2c09406663
Set id: 5697ae1d-ead6-46a0-8074-d83bdc0f4605
Version: 1
Effective Time: 20190227
 
Electrostim Medical Services Inc. d/b/a EMSI