BIOACTIL: Package Insert and Label Information

BIOACTIL- menthol gel
POLIMEROS Y SERVICIOS S.A.

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BIOACTIL
pain relieving gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69492-013
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 30 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN
CARBOMER 940
CETOSTEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
DIAZOLIDINYL UREA
METHYLPARABEN
ORTHOSILICIC ACID
SODIUM PHOSPHATE, DIBASIC
PROPYLPARABEN
SALICYLIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69492-013-07 1 TUBE in 1 BOX contains a TUBE
1 70 g in 1 TUBE This package is contained within the BOX (69492-013-07)
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 Operations
POLIMEROS Y SERVICIOS S.A. 815740251 manufacture (69492-013)

Revised: 03/2019 POLIMEROS Y SERVICIOS S.A.

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