DYNASHIELD WITH DIMETHICONE- zinc oxide cream 
Dynarex 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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1199 Dynashield with Dimethicone NDC 67777-408-03

Active Ingredients

Zinc Oxide 2%

Dimethicone 1.8%

Purpose

Uses

• Use as a general skin protectant

• Helps treat chafed skin associated with diaper rash

• Dries the oozing and weeping of poison ivy, oak, and sumac

Warnings

For External Use Only.

When using this product:

• Avoid contact with eyes

• Do not use over large areas of the body

• So not use if you are allergic to any of the ingredients

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 (1-800-222-1222) right away.

Directions

• For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply cream 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 between 15 0 - 30 0 C (59 0 - 86 0 F)

• Avoid excessive heat

• Tamper evident. Do not use if seal is damaged.

Inactive Ingredients

Aloe Vera Leaf, Alpha-Tocopherol (Vitamin E), Cetomacrogol 1000, Cetostearyl Alcohol, Cetyl Alcohol, Glycerin, Lanolin, Lavender Oil, Methylparaben, Mineral Oil, Propylparaben, Tartrazine, Trolamine, Vitamin A Acetate, Vitamin D3, Water, White Soft Paraffin

Questions and Comments?

1-888-396-2739, Monday - Friday 9AM-5PM EST

Label

1199 IN MASTERDynaShield with Dimehticone

DYNASHIELD WITH DIMETHICONE 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-408
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.8 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
VITAMIN A ACETATE (UNII: 3LE3D9D6OY)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LANOLIN (UNII: 7EV65EAW6H)  
CETETH-20 (UNII: I835H2IHHX)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-408-0224 in 1 CASE10/01/2014
1NDC:67777-408-03114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01610/01/2014
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 5/2023
Document Id: fb455abc-65ff-1124-e053-6394a90ade03
Set id: b5dcf9e8-4689-4a08-ae73-3a859b4cbffe
Version: 6
Effective Time: 20230509
 
Dynarex Corporation