Label: TOTAL MUSCLE RELIEF- menthol, camphor gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50130-108-13, 50130-108-16, 50130-108-23 - Packager: Electrostim Medical Services Inc. d/b/a EMSI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 27, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
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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
- DIRECTIONS
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOTAL MUSCLE RELIEF
menthol, camphor gelProduct 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)
