DYNASHIELD- zinc oxide ointment

Dynashield by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Zinc Oxide 1.8%

Purpose

​Skin Protectant

Uses

• Helps treat and prevent diaper rash
• Temporarily protects minor cuts scrapes burns
• Dries the oozing and weeping of poison ivy oak 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 within a few days

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

Directions

• For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
• For other uses: Apply as needed.

Other Information

• Store at room temperature
• Avoid excessive heat

Inactive Ingredients

Glycerin USP, Cetostearyl Alcohol USP, Cetyl Alcohol USP, White Petrolatum USP (white soft paraffin), Mineral Oil USP, Anhyudrous Lanolin USP, Cetomacrogol 1000 BP, Aloe vera Extract, Methyl Paraben USP, Propyl Paraben USP, Perfume Lavander K748, Alpha Tocopherol USP, Trolamine USP (Triethanolamine), Vitamin A USP, Cholecalciferol (Vitamin D3) USP, FD&C Yellow No. 5 (tartrazine)

Labeling

INGREDIENTS AND APPEARANCE

DYNASHIELD 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-407
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PETROLATUM (UNII: 4T6H12BN9U)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-407-01	5 g in 1 PACKET; Type 0: Not a Combination Product	05/23/2018
2	NDC: 67777-407-02	15 g in 1 PACKET; Type 0: Not a Combination Product	05/23/2018
3	NDC: 67777-407-03	114 g in 1 TUBE; Type 0: Not a Combination Product	05/23/2018
4	NDC: 67777-407-04	427.5 g in 1 JAR; Type 0: Not a Combination Product	05/23/2018

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)