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Diaper Rash by Kareway Product, Inc.

Medically reviewed on September 1, 2017

Dosage form: cream
Ingredients: ZINC OXIDE 0.1g in 1g
Labeler: Kareway Product, Inc.
NDC Code: 67510-0502

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 ingredient

Zinc Oxide 10%

Purpose

Skin Protectant

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect skin from wetness
  • helps prevent and temporarily protect chafed, chapped, cracked or windburned skin lips

Warnings

For external use only

Do not use

over deep or puncture wounds, infections or lacerations

When using this product

avoid contact with the eyes

Stop use and ask a doctor

if condition worsens or does not improve within 7 days.

Keep out of reach of children.

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

Directions
  • change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information
  • store at room temperature
  • Lot No and Exp Date: see box or see crimp of tube

Inactive ingredients

Talc, Vacillin, Bees wax, Demethicone, Liquid paraffin, Tocopherol acetate, Sesquioleate sorbitan, Aloe vera gel, Methylparaben, Propylparaben, Purified water

Package label

Diaper Rash Cream

DIAPER RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0502
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
TALC 
AMPICILLIN TRIHYDRATE 
PEG-12 DIMETHICONE 
MINERAL OIL 
TOCOPHEROL 
SORBITAN SESQUIOLEATE 
ALOE VERA LEAF 
METHYLPARABEN 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:67510-0502-21 TUBE in 1 BOX
157 g in 1 TUBE
2NDC:67510-0502-41 TUBE in 1 BOX
2114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/25/2011
Labeler - Kareway Product, Inc. (121840057)

 
Kareway Product, Inc.

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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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