Vitacilina Bebe Diaper Rash Ointment

Vitacilina Bebe Diaper Rash Ointment
SPL v3
SPL
SPL Set ID 6701e929-700e-40a4-9117-81e36577bfe1
Route
TOPICAL
Published
Effective Date 2022-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (400 mg)
Inactive Ingredients
Aloe Vera Leaf Butylated Hydroxyanisole Cetyl Alcohol Starch, Corn Hydroxyethyl Cellulose, Unspecified Lanolin Methylparaben Mineral Oil Petrolatum Polysorbate 20 Water Shea Butter

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-07-01 Until 2027-10-17

Description

Zinc Oxide 40%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 40%

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

For external use only.

Avoid contact with eyes.

Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area 
  • allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
Drug Facts

Active Ingredient

Zinc Oxide 40%

Other Information
  • store at 15 to 30°C (59 to 86°F)
  • DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING. Tamper Evident:
Package Labeling:

Inactive Ingredients

paccohol, coconut butter, corn starch, fragrance, hydroxyethylcellulose, lanolin, methylparaben, mineral oil, petrolatum, polysorbate 20, purified water, shea butter

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: 800-222-1222.


Structured Label Content

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

Skin Protectant

Warnings

For external use only.

Avoid contact with eyes.

Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area 
  • allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
Drug Facts

Active Ingredient (Active ingredient)

Zinc Oxide 40%

Other Information (Other information)
  • store at 15 to 30°C (59 to 86°F)
  • DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING. Tamper Evident:
Package Labeling:

Inactive Ingredients (Inactive ingredients)

paccohol, coconut butter, corn starch, fragrance, hydroxyethylcellulose, lanolin, methylparaben, mineral oil, petrolatum, polysorbate 20, purified water, shea butter

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: 800-222-1222.


Advanced Ingredient Data


Raw Label Data

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