Label: SOOTHANOL X2- capsaicin and menthol solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 50972-766-01 - Packager: NewMarket Health Products LLC
- 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 August 31, 2017
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only.
When using this product
- avoid contact with eyes or mucus membranes
- do not bandage tighly
- do not apply to wounds or damaged skin
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOOTHANOL X2
capsaicin and menthol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50972-766 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 2 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 120 mg in 1 g Inactive Ingredients Ingredient Name Strength ARNICA ANGUSTIFOLIA FLOWER (UNII: NG0U89QRD8) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) DIMETHYL SULFOXIDE (UNII: YOW8V9698H) LIMONENE, (+)- (UNII: GFD7C86Q1W) EMU OIL (UNII: 344821WD61) OLIVE OIL (UNII: 6UYK2W1W1E) GINGER (UNII: C5529G5JPQ) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ST. JOHN'S WORT (UNII: UFH8805FKA) METHYL SALICYLATE (UNII: LAV5U5022Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50972-766-01 1 in 1 BOX 06/11/2014 1 28.3 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/11/2014 Labeler - NewMarket Health Products LLC (055293706) Establishment Name Address ID/FEI Business Operations Vitality Works, Inc. 137752817 manufacture(50972-766)