babysons

babysons
SPL v4
SPL
SPL Set ID 8a4782fc-5917-4f63-b9bf-6597be2afc6c
Route
topical
Published
Effective Date 2020-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dexpanthenol (50 mg)
Inactive Ingredients
lanolin yellow wax cetyl alcohol polysorbate 60 polysorbate 80 stearyl alcohol water petrolatum zinc oxide

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2020-06-15
Purpose

Skin Protectant

Description

Dexpanthenol 5%

Medication Information

Warnings

For external use only

Uses
  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness
Purpose

Skin Protectant

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

Keep the tube tightly closed and store at no higher temperature than 86°F / 30°C.

Inactive Ingredients

anhydrous lanolin, beeswax, cetyl alcohol, polysorbate 60, polysorbate 80, stearyl alcohol, water, white petrolatum, zinc oxide

Description

Dexpanthenol 5%

Active Ingredient

Dexpanthenol 5%

Package Labeling:

When Using This Product
  • do not get into eyes.
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.

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
  • Protects chafed skin due to diaper rash and helps seal out wetness
Purpose

Skin Protectant

Directions
  • Change wet and soiled diapers promptly.
  • Cleanse the diaper area and allow to dry
  • Apply product 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)

Keep the tube tightly closed and store at no higher temperature than 86°F / 30°C.

Inactive Ingredients (Inactive ingredients)

anhydrous lanolin, beeswax, cetyl alcohol, polysorbate 60, polysorbate 80, stearyl alcohol, water, white petrolatum, zinc oxide

Active Ingredient (Active ingredient)

Dexpanthenol 5%

Package Labeling:

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)
  • 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.)

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: 2026-02-15T12:04:10.254552 · Updated: 2026-03-14T23:04:41.766336