BIODCREAM- zinc oxide cream 
Advanced Generic Corporation

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.

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Active Ingredient

Zinc Oxide 15.25%

Purpose

Skin protectant

Uses

Warnings

For external use only. 

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

Inactive ingredients

beeswax, butylated hydroxyl anisole, diazolidinyl urea, lanolin oil, lavender fragrance, methylparaben, paraffinum liquidum, propylene glycol, propylparaben, white petrolatum.

Questions or comments:

1-305-403-3788

BioDcreamBioDcream

BIODCREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
MINERAL OIL (UNII: T5L8T28FGP)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LANOLIN OIL (UNII: OVV5IIJ58F)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-701-04125 g in 1 JAR; Type 0: Not a Combination Product04/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/01/2016
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2020
Document Id: 56418335-c450-468d-8ff1-37747778a7f6
Set id: 89a3a755-0928-471b-95ed-8b07d08e4675
Version: 4
Effective Time: 20201223
 
Advanced Generic Corporation