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
Description

Dexpanthenol 5%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Dexpanthenol 5%

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

For external use only

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.
Active Ingredient

Dexpanthenol 5%

Other Information

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

Package Labeling:

Inactive Ingredients

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

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

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

Skin Protectant

Warnings

For external use only

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.
Active Ingredient (Active ingredient)

Dexpanthenol 5%

Other Information (Other information)

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

Package Labeling:

Inactive Ingredients (Inactive ingredients)

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

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