3988c83b-d4eb-1f09-e063-6394a90a45ad

SPL v2
SPL
SPL Set ID 3988c83b-d4eb-1f09-e063-6394a90a45ad
Route
topical
Published
Effective Date 2025-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (12 g) dimethicone (1 g)
Inactive Ingredients
corn oil imidazolidinyl urea lanolin mineral oil water paraffin aloe vera leaf cholecalciferol phenoxyethanol .alpha.-tocopherol acetate sorbitan sesquioleate vitamin a palmitate petrolatum chloroxylenol propylene glycol ethylhexylglycerin aluminum stearate beeswax

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2025-07-09
Purpose

Skin Protectant

Description

Dimethicone 1% w/w Zinc Oxide 12% w/w

Medication Information

Warnings

Warnings

  • For external use only
Uses
  • Helps treat and prevent diaper rash.
  • Protects minor skin irritation associated with diaper rash and helps seal out wetness.
Purpose

Skin Protectant

Directions

Directions

  • Change wet and soiled diaper promptly
  • Cleanse the diaper area, and allow to dry
  • Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Inactive Ingredients

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Aluminum Stearate, Beeswax, Cholecalciferol, Chloroxylenol, Corn Oil, Ethylhexylglycerin, Fragrance, Imidazolidinyl Urea, Lanolin, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Propylene Glycol, Sorbitan Sesquioleate, Tocopherol Acetate, Vitamin A Palmitate, Water

Description

Dimethicone 1% w/w Zinc Oxide 12% w/w

Section 51945-4

Active Ingredients

Dimethicone 1% w/w

Zinc Oxide 12% w/w

When Using This Product

When using this product do not get into the eyes

Stop Use and Ask A Doctor If

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children.

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Structured Label Content

Warnings

Warnings

  • For external use only
Uses
  • Helps treat and prevent diaper rash.
  • Protects minor skin irritation associated with diaper rash and helps seal out wetness.
Purpose

Skin Protectant

Directions

Directions

  • Change wet and soiled diaper promptly
  • Cleanse the diaper area, and allow to dry
  • Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Inactive Ingredients

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Aluminum Stearate, Beeswax, Cholecalciferol, Chloroxylenol, Corn Oil, Ethylhexylglycerin, Fragrance, Imidazolidinyl Urea, Lanolin, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Propylene Glycol, Sorbitan Sesquioleate, Tocopherol Acetate, Vitamin A Palmitate, Water

Section 51945-4 (51945-4)

Active Ingredients

Dimethicone 1% w/w

Zinc Oxide 12% w/w

When Using This Product (When using this product)

When using this product do not get into the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:30.689615 · Updated: 2026-03-14T23:09:19.585027