Your browser does not support JavaScript! DYNASHIELD WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [DYNAREX CORPORATION]
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DYNASHIELD WITH DIMETHICONE (zinc oxide and dimethicone) cream
[Dynarex Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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.

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Dynashield with Dimethicone

Dynashield



DYNASHIELD  WITH DIMETHICONE
zinc oxide and dimethicone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67777-228
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE200 mg  in 1 g
DIMETHICONE (DIMETHICONE) DIMETHICONE18 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CETYL ALCOHOL 
CHOLECALCIFEROL 
LANOLIN 
METHYLPARABEN 
MINERAL OIL 
PETROLATUM 
WATER 
CETETH-10 
PARAFFIN 
PROPYLPARABEN SODIUM 
GLYCERIN 
PHENOXYETHANOL 
STEARETH-20 
POLYETHYLENE GLYCOL 6000 
POLYSORBATE 60 
CETOSTEARYL ALCOHOL 
VITAMIN A 
ALPHA-TOCOPHEROL 
TROLAMINE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-228-0124 in 1 CARTON
1113.4 g in 1 TUBE
2NDC:67777-228-02144 in 1 BOX
25 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/01/2009
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 5/2014
 
Dynarex Corporation

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