vitacilina bebe diaper rash ointment

vitacilina bebe diaper rash ointment
SPL v20
SPL
SPL Set ID 39726b59-bd85-4541-80e5-4f2919842dca
Route
topical
Published
Effective Date 2025-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
allantoin (10 mg) zinc cation (250 mg)
Inactive Ingredients
petrolatum starch, corn lanolin methylparaben mineral oil propylparaben vitamin a vitamin d .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2013-09-30

Purpose

Skin Protectant

Description

Allantoin 1% Zinc Oxide 25%


Medication Information

Warnings

For external use only.

Uses

• Helps treat and prevent diaper rash • Protects against minor skin irritation associated with diaper rash • Helps seal out wetness.

Purpose

Skin Protectant

Directions

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

Inactive Ingredients

Petrolatum, Corn starch, Fragrance, Lanolin, Methylparaben, Mineral oil, Propylparaben, Vitamin A Palmitate, Vitamin D (calciferol), Vitamin E (tocopherol).

Description

Allantoin 1% Zinc Oxide 25%

Drug Facts

Package Labeling:

Active Ingredients

Allantoin 1%

Zinc Oxide 25%

Questions Or Comments?

Call 1-855-289-3205 (toll-free) or email [email protected]

When Using This Product
  • avoid contact with the 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 the Reach of Children.


Structured Label Content

Warnings

For external use only.

Uses

• Helps treat and prevent diaper rash • Protects against minor skin irritation associated with diaper rash • Helps seal out wetness.

Purpose

Skin Protectant

Directions

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

Inactive Ingredients

Petrolatum, Corn starch, Fragrance, Lanolin, Methylparaben, Mineral oil, Propylparaben, Vitamin A Palmitate, Vitamin D (calciferol), Vitamin E (tocopherol).

Drug Facts

Package Labeling:

Active Ingredients (Active ingredients)

Allantoin 1%

Zinc Oxide 25%

Questions Or Comments? (Questions or comments?)

Call 1-855-289-3205 (toll-free) or email [email protected]

When Using This Product (When using this product)
  • avoid contact with 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 the Reach of Children. (Keep out of the reach of children.)


Advanced Ingredient Data


Raw Label Data

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