ZINC OXIDE- zinc oxide ointment 
Blossom Pharmaceuticals

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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Zinc Oxide Ointment

Active Ingredient

Section Text

Active Ingredient                            Purpose

Zinc Oxide (200mg in each gram)   Skin Protectant

Purpose:

Warnings:

For External Use Only

When using this product:

Stop use and ask a doctor if:

Indications & Usage:

Keep out of reach of children

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

Dosage & Administration:

For diaper rash:

For poison ivy, poison oak, poison sumac:

Inactive Ingredients

Cetostearyl alcohol, Cetomacrogal 1000, Light Liquid Paraffin, White Soft Paraffin

Principal Display

Blossom Pharmaceuticals Zinc Oxide

zinc oxide.jpg

Blossom Pharmaceuticals zinc oxide

ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61767-222
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61767-222-0372 in 1 CASE
128.34 g in 1 TUBE
2NDC:61767-222-0172 in 1 CASE
256.68 g in 1 TUBE
3NDC:61767-222-0212 in 1 CASE
3425.1 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/14/2014
Labeler - Blossom Pharmaceuticals (677381470)
Establishment
NameAddressID/FEIBusiness Operations
Blossom Pharmaceuticals677381470manufacture(61767-222)

Revised: 5/2014
Document Id: 0aeacffd-4c75-4018-bbd6-f734980cb2b5
Set id: ff614241-78d3-4112-acfd-97527493c578
Version: 1
Effective Time: 20140514
 
Blossom Pharmaceuticals