DYNA1199 WITH DIMETHICONE- 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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Dyna1199 with Dimethicone Ointment

Active Ingredient               Purpose

Zinc Oxide 2%                   Diaper Rash

Dimethicone 1.8%              Skin Protectant

Purpose:

Warnings:

For External Use Only.

When using this product:

Do not get in eyes.

Stop use and ask a doctor if:

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Dosage and Administration:

           For poison ivy, oak and sumac:

           For diaper Rash:

Other information:

Indications: For use as a general skin protectant and diaper rash.

Inactive ingredients:

Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-20, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender perfume, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Trolamine, Vitamin A, Water

Principal Display Panel

DynaShield Skin Protectant

DynaDi1199.jpg

Dyna1199 with Dimethicone

DYNA1199 WITH DIMETHICONE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61767-228
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
CETETH-20 (UNII: I835H2IHHX)  
MINERAL OIL (UNII: T5L8T28FGP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
VITAMIN A (UNII: 81G40H8B0T)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PETROLATUM (UNII: 4T6H12BN9U)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61767-228-015 g in 1 PACKET
2NDC:61767-228-0215 g in 1 PACKET
3NDC:61767-228-03114 g in 1 TUBE
4NDC:61767-228-04427.5 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/23/2014
Labeler - Blossom Pharmaceuticals (677381470)

Revised: 10/2014
Document Id: 3cfaedb1-70c1-43ee-baf5-5ff1b3454443
Set id: fae1e98a-5032-42d5-9117-e3501710c237
Version: 1
Effective Time: 20141023
 
Blossom Pharmaceuticals