Quality Choice Zinc Oxide Ointment Usp

Quality Choice Zinc Oxide Ointment Usp
SPL v3
SPL
SPL Set ID acdb3a7d-415b-e823-e053-2995a90a654c
Route
TOPICAL
Published
Effective Date 2020-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.2 g)
Inactive Ingredients
Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-08-14

Description

Zinc Oxide 20%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 20%

Uses
  • 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
Section 51945-4

Warnings

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.
Directions
  • 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
Distributed By:

Distributed by CDMA Inc.

43157 W 9 Mile Rd

Novi, MI. 48375

Product of PRC

www.qualitychoice.com

Questions: 800-935-2362

Active Ingredient

Zinc Oxide 20%

Other Information
  • Store at controlled room temperature 15° - 30°C (59° - 86°F)
Inactive Ingredients

Mineral Oil, Petrolatum

Keep Out of the Reach of Children

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


Structured Label Content

Uses
  • 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
Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warnings

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.
Directions
  • 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
Distributed By:

Distributed by CDMA Inc.

43157 W 9 Mile Rd

Novi, MI. 48375

Product of PRC

www.qualitychoice.com

Questions: 800-935-2362

Active Ingredient

Zinc Oxide 20%

Other Information
  • Store at controlled room temperature 15° - 30°C (59° - 86°F)
Inactive Ingredients

Mineral Oil, Petrolatum

Keep Out of the Reach of Children (Keep out of the reach of children)

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


Advanced Ingredient Data


Raw Label Data

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