DYNASHIELD WITH DIMETHICONE- zinc oxide ointment

Dynashield with Dimethicone by

Drug Labeling and Warnings

Dynashield with Dimethicone by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient               Purpose

Zinc Oxide 2%                   Diaper Rash

Dimethicone 1.8%              Skin Protectant

Purpose:

• Helps treat and prevent diaper rash
• Dries the oozing and weeping of;
• poison ivy
• poison oak
• poison sumac

Warnings:

For External Use Only.

When using this product:

Do not get in eyes.

Stop use and ask a doctor if:

• condition worsens
• symptoms last more than 7 days or clear up and occur again in a few days, consult a physician
• over large areas of the body
• if you are allergic to any of these ingredients

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:

• Apply ointment liberally as often as needed

           For diaper Rash:

• change wet and soiled diapers promptly
• clean the diaper area and allow to dry
• apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other information:

• Do not use if seal is punctured or not visible
• Store at room temperature 15 0 - 30 0 C (59 0 - 86 0 F)
• avoid excessive heat
• contains color additives including FDC yellow # 5 (Tartrazine)

INDICATIONS & USAGE

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

INACTIVE INGREDIENT

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

Dynarex DynaShield Skin Protectant

dynashield dimeth.jpg

INGREDIENTS AND APPEARANCE

DYNASHIELD WITH DIMETHICONE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-408
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
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)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-408-03	114 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/01/2014

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)