Zinc Oxide 20%: Package Insert and Label Information

ZINC OXIDE 20%- zinc oxide ointment
Chain Drug Marketing Association Inc.

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%


Skin Protectant


  • Protects skin
  • Protects and releives chafed skin due to diaper rash — helps seal out wetness
  • Dries the oozing and weeping of poison ivy, oak and sumac

Keep out of the reach of children

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


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 within 7 days. This may be a sign of a serious condition.


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

Other Information

  • Store at controlled room temperature 15° — 30°C (59° — 86°F)

Inactive Ingredients

Mineral Oil, Petrolatum

Distributed By:

Distributed by CDMA Inc.

43157 W 9 Mile Rd

Novi, MI. 48375

Product of PRC


Questions: 800-935-2362

QC zinc oxide 2oz
(click image for full-size original)

zinc oxide ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-686
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
# Item Code Package Description Multilevel Packaging
1 NDC:63868-686-02 1 TUBE in 1 BOX contains a TUBE
1 57 g in 1 TUBE This package is contained within the BOX (63868-686-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 08/14/2020
Labeler — Chain Drug Marketing Association Inc. (011920774)
Registrant — Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 05/2023 Chain Drug Marketing Association Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.