Label: TOTAL MUSCLE RELIEF- menthol, camphor spray
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Contains inactivated NDC Code(s)
NDC Code(s): 50130-109-14 - 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 16, 2019
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- 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 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
- DIRECTIONS
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOTAL MUSCLE RELIEF
menthol, camphor sprayProduct 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)