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Zinc Oxide by H&H Laboratories, Inc.

Dosage form: ointment
Ingredients: ZINC OXIDE 200mg in 1g
Labeler: H&H Laboratories, Inc.
NDC Code: 52471-116

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 20%

Purpose: Skin Protectant

Dries the oozing and weeping of poison ivy, poison oak, and sumac.  Helps treat/prevent diaper rash. Protects chafed skin associated with diaper rash and helps protect from wetness.


For external use only. When using this product, avoid contact with eyes.

Stop use and ask a doctor if condition worsens or does not improve in 7 days


Directions:  Apply liberally as often as necessary.  For diaper rash: Change wet and soiled diapers promptly.  Cleanse the diaper area and allow to dry.  Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Inactive Ingredient:  White Petrolatum

MM1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52471-116
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:52471-116-481 TUBE (TUBE) in 1 CARTON
1NDC:52471-116-0128 g in 1 TUBE
2NDC:52471-116-16454 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34705/03/2012
Labeler - H&H Laboratories, Inc. (151357175)
Registrant - H&H Laboratories, Inc. (151357175)
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004manufacture

Revised: 05/2012
 
H&H Laboratories, 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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