Vitacilina Bebe Diaper Rash Ointment
FDA Label NDC 81929-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Taisho Pharmaceutical California Inc. for the product Vitacilina Bebe Diaper Rash (NDC 81929-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Zinc Oxide 40%
Purpose
Skin Protectant
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.
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.
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
Other Information
- store at 15 to 30°C (59 to 86°F)
- Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
Inactive Ingredients
paccohol, coconut butter, corn starch, fragrance, hydroxyethylcellulose, lanolin, methylparaben, mineral oil, petrolatum, polysorbate 20, purified water, shea butter
Package Labeling:
Label (Label)
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