Label: BIOACTIL- pain relieving gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69492-013-07 - Packager: POLIMEROS Y SERVICIOS S.A.
- 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 March 13, 2019
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- Detail showing Active Ingredient from package
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- Detail showing Dosage and Administration within Directions from package
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- Representative sample image of carton/container label
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INGREDIENTS AND APPEARANCE
BIOACTIL
pain relieving gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69492-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 30 mg in 1 g Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) CARBOMER 940 (UNII: 4Q93RCW27E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) ORTHOSILICIC ACID (UNII: 623B93YABH) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) PROPYLPARABEN (UNII: Z8IX2SC1OH) SALICYLIC ACID (UNII: O414PZ4LPZ) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69492-013-07 1 in 1 BOX 03/12/2019 1 70 g in 1 TUBE; 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 03/12/2019 Labeler - POLIMEROS Y SERVICIOS S.A. (815740251) Establishment Name Address ID/FEI Business Operations POLIMEROS Y SERVICIOS S.A. 815740251 manufacture(69492-013)