Vitabath Baby Soothing Relief Diaper Rash
FDA Label NDC 73172-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vitabath Inc. for the product Vitabath Baby Soothing Relief Diaper Rash (NDC 73172-004). 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 active ingredients, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Zinc Oxide 14% w/w

Purpose

Skin protectant

Uses

Uses: •helps treat and prevent diaper rash •protects
chafed skin due to diaper rash •helps seal out wetness

Warnings

For external use only.

Otc - When Using

When using this product •avoid contact with eyes

When using this product •avoid contact with eyes

Otc - Stop Use

Stop use and ask a doctor if •condition worsens or
does not improve within 7 days.

Otc - 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.

Dosage & Administration

Directions: Change wet or soiled diapers promptly.
Clean the diaper area and allow to dry. Apply cream
liberally as often as necessary, with each diaper change,
especially at bedtime or any time exposure to wet
diapers may be prolonged.

Other Safety Information

Other Information: •Remove quality seal. •Do not use if
quality seal is broken.

Inactive Ingredient

Inactive Ingredients: Helianthus Annuus (Sunflower)
Seed Oil, Beeswax white, Ricinus Communis (Castor)
Seed Oil, Butyrospermum Parkii (Shea) Butter, Cocos
Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit
Oil, Tocopherol, Salvia Sclarea (Clary) Oil, Simmondsia
Chinensis (Jojoba) Seed Oil, Vitis Vinifera (Grape)
Seed Oil, Avena Sativa (Oat) Kernel Oil, Calophyllum
Inophyllum Seed Oil.

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