BIOACTIL- pain relieving gel

BIOACTIL by

Drug Labeling and Warnings

BIOACTIL by is a Otc medication manufactured, distributed, or labeled by POLIMEROS Y SERVICIOS S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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INGREDIENTS AND APPEARANCE

BIOACTIL 
pain relieving gel

Product 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)