ZINC OXIDE AND DIMETHICONE WITH DIMETHICONE- zinc oxide and dimethicone cream

Zinc Oxide and Dimethicone by

Drug Labeling and Warnings

Zinc Oxide and Dimethicone by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Purpose:

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

Warnings:

For external use only

Dosage and Administration:

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

GalShield with Dimethicone

GalShield D.jpg

INGREDIENTS AND APPEARANCE

ZINC OXIDE AND DIMETHICONE  WITH DIMETHICONE
zinc oxide and dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	18 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-012-01	113.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/08/2013

Labeler - Galentic Pharma (India) Private Limited (918531450)