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Zinc Oxide by Topco Associates LLC

Medically reviewed on July 30, 2018

Dosage form: ointment
Ingredients: ZINC OXIDE 20g in 100g
Labeler: Topco Associates LLC
NDC Code: 36800-100

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 20%

Purpose

Skin Protectant

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash
  • helps seal out wetness

For external use only.

When using this product
  • do not get into eyes

Stop use and ask a doctor if
  • condition worsens
  • symptoms last more than 7 days or clear up and occur within a few days.

Keep out of reach of children.

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

Directions
  • change wet or soiled diapers promptly
  • clean the diaper area
  • allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.

Other Information
  • store at 20-25°C (68-77°F)

Inactive Ingredients

bees wax, BHT, cod liver oil, fragrance, lanolin, methylparaben, petrolatum, purified water

ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COD LIVER OIL 
LANOLIN 
METHYLPARABEN 
PETROLATUM 
WATER 
Packaging
#Item CodePackage Description
1NDC:36800-100-021 TUBE in 1 BOX
156.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/01/2013
Labeler - Topco Associates LLC (006935977)

 
Topco Associates LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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