Label: ONE GEL SPORT PAIN RELIEVING (camphor- synthetic and menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69023-100-30 - Packager: Phyto Creativ
- 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 22, 2014
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 ml Bottle Label
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INGREDIENTS AND APPEARANCE
ONE GEL SPORT PAIN RELIEVING
camphor (synthetic) and menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69023-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic) 30 mg in 1 mL Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 22 mg in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) equisetum arvense branch (UNII: 1L0VKZ185E) fd&c blue no. 1 (UNII: H3R47K3TBD) linalool, (+/-)- (UNII: D81QY6I88E) potassium sorbate (UNII: 1VPU26JZZ4) sodium benzoate (UNII: OJ245FE5EU) sodium hydroxide (UNII: 55X04QC32I) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69023-100-30 100 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 07/04/2014 Labeler - Phyto Creativ (263842260) Establishment Name Address ID/FEI Business Operations Phyto Creativ 263842260 MANUFACTURE(69023-100)