Dynashield description, usages, side effects, indications, overdosage, supplying and lots more!

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Dynashield

Dynarex Corporation
Dynarex Corporation

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

Dynashield Zinc Oxide / Dimethicone


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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

Principal Display Panel



Dynashield

zinc oxide and dimethicone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67777-228
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Zinc Oxide Zinc oxide 200 mg
DIMETHICONE 18 mg

Inactive Ingredients

Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 113.4 in 1 TUBE
2 5 in 1 PACKET
3 NDC:67777-228-02 144 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2009-09-01


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