DYNASHIELD WITH DIMETHICONE- zinc oxide and dimethicone 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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Dynashield Zinc Oxide / Dimethicone On Hold - Zinc Oxide is in the wrong concentration.

Active ingredient        Purpose
Zinc Oxide (200 mg)      Diaper Rash
Dimethicone 1.8%         Skin Protectant

Uses:

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

Warnings:

For external use only

Directions:

For diaper rash

  • change wet and soiled diapers promptly
  • cleanse 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

For poison ivy, oak and sumac

  • apply ointment liberally as often as needed

Other information

  • Do not use if seal is punctured or not visible
  • store at room temperature 15°-30° C (59°-86° F)
  • avoid excessive heat

Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Cholecaliferol, Diazolidinyl Urea, Fragrance, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Purified Water, Retinyl Palmitate, Sodium Borate, Stearic Acid, Tocopheryl Acetate, Yellow 5, Yellow 6, Zea Mays (Corn) oil

Stop use if

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

Indications and Usage

Indications are for diaper rash and general skin protectant.

Do not use

  • deep or puncture wounds
  • animal bites
  • serious burns

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.

Principal Display Panel

Dynashield with Dimethicone

Dynashield



DYNASHIELD  WITH DIMETHICONE
zinc oxide and dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-228
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
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE18 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
CETETH-10 (UNII: LF9X1PN3XJ)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARETH-20 (UNII: L0Q8IK9E08)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
VITAMIN A (UNII: 81G40H8B0T)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-228-0124 in 1 CARTON09/01/2009
1113.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/01/200903/15/2019
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 3/2019
 
Dynarex Corporation