a1b29d42-fe42-4a26-a93d-84609bfe36e1

SPL v1
SPL
SPL Set ID a1b29d42-fe42-4a26-a93d-84609bfe36e1
Route
topical
Published
Effective Date 2016-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (16 g)
Inactive Ingredients
castor oil mineral oil paraffin balsam peru petrolatum

Identifiers & Packaging

Marketing Status
export only active Since 2008-07-31
Description

Zinc Oxide, 16%........Skin Protectant

Medication Information

Warnings
  • For external use only.
  • When using this product avoid contact with the eyes.
Uses
  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness
Other Information
  • Store at room temperature, 20C to 27C (68F to 80F).
  • Use with infants, children and adults.
  • Will stain clothing and fabric.
Inactive Ingredients

Castor Oil, Mineral Oil, Paraffin, Peruvian Balsam, Petrolatum

Description

Zinc Oxide, 16%........Skin Protectant

Questions?

Call toll free 1-855-785-2888

Section 51945-4

Active Ingredient

Zinc Oxide, 16%........Skin Protectant

Directions for Use
  • Change wet and soiled diaper immediately.
  • Cleanse the diaper area and allow to dry.
  • Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime.
Stop Use and Ask A Doctor If

Condition worsens or does not improve after 7 days.

Structured Label Content

Warnings
  • For external use only.
  • When using this product avoid contact with the eyes.
Uses
  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness
Other Information
  • Store at room temperature, 20C to 27C (68F to 80F).
  • Use with infants, children and adults.
  • Will stain clothing and fabric.
Inactive Ingredients

Castor Oil, Mineral Oil, Paraffin, Peruvian Balsam, Petrolatum

Questions?

Call toll free 1-855-785-2888

Section 51945-4 (51945-4)

Active Ingredient

Zinc Oxide, 16%........Skin Protectant

Directions for Use
  • Change wet and soiled diaper immediately.
  • Cleanse the diaper area and allow to dry.
  • Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Condition worsens or does not improve after 7 days.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:05.662935 · Updated: 2026-03-14T22:54:18.927073