Skin Protectant

Dosage form: cream
Ingredients: ZINC OXIDE 120mg in 1g, DIMETHICONE 20mg in 1g
Labeler: Tiger Medical Group (US), Inc.
NDC Code: 75934-0003

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.

Drug Facts

Active Ingredients

Zinc Oxide  12%

Dimethicone  2%

Purpose

Zinc Oxide  Diaper Rash

Dimethicone  Skin Protectant

Uses

Helps treat and prevent minor skin irritation due to diaper rash. Helps seal out wetness.

Keep out of reach from children.

Directions

Change wet and soiled diapers promptly.

Apply to affected area and gently wipe with clean, soft cloth.

Apply as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Inactive Ingredients

Purified Water, Petrolatum, Liquid Paraffin, PEG-4 Stearate, Glycerin, Lanolin Oil, Cetearyl Alcohol, Tocopheryl Acetate, Glyceryl Stearate, Cod Liver Oil, Quaternium-15, BHT, Ethylparaben, Disodium EDTA, Fragrance, Tricontanyl PVP.

Warnings

For external use only.

If swallowed, get medical help or contact a Poison Control Center right away.

When using this product

avoid contact with eyes

do not apply to deep or puncture wounds or lacerations.

Stop use and consult a doctor if condition worsens or does not improve within 7 days.

Net Wt. 1/2 oz. (14.2g)

SKIN PROTECTANT 
zinc oxide, dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75934-0003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE120 mg  in 1 g
DIMETHICONE (DIMETHICONE) DIMETHICONE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
PETROLATUM 
MINERAL OIL 
PEG-4 STEARATE 
GLYCERIN 
LANOLIN OIL 
CETOSTEARYL ALCOHOL 
ALPHA-TOCOPHEROL ACETATE 
GLYCERYL MONOSTEARATE 
COD LIVER OIL 
QUATERNIUM-15 
BUTYLATED HYDROXYTOLUENE 
ETHYLPARABEN 
EDETATE DISODIUM 
TRIACONTANYL PVP (WP-660) 
PEG-100 STEARATE 
Packaging
#Item CodePackage Description
1NDC:75934-0003-114.2 g in 1 PACKAGE
2NDC:75934-0003-2113.6 g in 1 TUBE
3NDC:75934-0003-3227 g in 1 TUBE
4NDC:75934-0003-4454.4 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2012
Labeler - Tiger Medical Group (US), Inc. (544980548)

Revised: 01/2012
 
Tiger Medical Group (US), Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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