sudocrem skin protectant cream

sudocrem skin protectant cream
SPL v1
SPL
SPL Set ID 20d2cf0b-d237-fd78-e063-6394a90a8d03
Route
topical
Published
Effective Date 2024-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (152.9 mg)
Inactive Ingredients
water lanolin linalyl acetate benzyl cinnamate benzyl benzoate sodium benzoate microcrystalline wax paraffin propylene glycol butylated hydroxyanisole yellow wax benzyl alcohol lavender oil sorbitan sesquioleate citric acid monohydrate stearic acid cetyl alcohol cetyl esters wax

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-08-06
Purpose

Skin protectant

Description

Zinc oxide (15.29%)

Medication Information

Warnings

For external use only.

Uses
  • Helps treat and prevent Diaper Rash and Incontinence Dermatitis
  • Protects chafed skin and minor skin irritations due to diaper rash and helps protect from wetness
Purpose

Skin protectant

Directions
  • Apply as needed
  • For diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow it 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.
Other Information
  • Store at room temperature between 15C and 30C (59F to 86F)
  • Do not use if safety seal is broken or missing
Inactive Ingredients

beeswax, benzyl alcohol, benzyl benzoate, benzyl cinnamate, BHA, cetyl esters, cetyl alcohol, citric acid, lanolin, lavender oil, linalyl acetate, liquid paraffin, microcrystalline wax, paraffin wax, propylene glycol, sodium benzoate, sorbitan sesquioleate, stearic acid, water

Description

Zinc oxide (15.29%)

Active Ingredient

Zinc oxide (15.29%)

Product Packaging

When Using This Product
  • do not get into eyes
Stop Use and Ask A Doctor If
  • conditions worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away

Structured Label Content

Warnings

For external use only.

Uses
  • Helps treat and prevent Diaper Rash and Incontinence Dermatitis
  • Protects chafed skin and minor skin irritations due to diaper rash and helps protect from wetness
Purpose

Skin protectant

Directions
  • Apply as needed
  • For diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow it 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.
Other Information (Other information)
  • Store at room temperature between 15C and 30C (59F to 86F)
  • Do not use if safety seal is broken or missing
Inactive Ingredients (Inactive ingredients)

beeswax, benzyl alcohol, benzyl benzoate, benzyl cinnamate, BHA, cetyl esters, cetyl alcohol, citric acid, lanolin, lavender oil, linalyl acetate, liquid paraffin, microcrystalline wax, paraffin wax, propylene glycol, sodium benzoate, sorbitan sesquioleate, stearic acid, water

Active Ingredient (Active ingredient)

Zinc oxide (15.29%)

Product Packaging

When Using This Product (When using this product)
  • do not get into eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • conditions 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.)

If swallowed, get medical help or contact a Poison Control Center right away

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:30.361099 · Updated: 2026-03-14T23:03:35.185430