Babyspa
FDA Label NDC 42957-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Expro3 Llc for the product Babyspa (NDC 42957-001). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts
Active Ingredients            Purpose
Zinc Oxide 12%......................Skin Protectant

Otc - Purpose

Uses:    * Helps treat and prevent diaper rash and other minor skin irritations    * Seals out wetness

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away(U.S. -- 1-800-222-1222)

Indications & Usage

Directions:Apply cream liberally, as often as necessary, with each diaper change for continuous protection

Warnings

Warnings:For external use only

Dosage & Administration

Stop use and ask a doctor if:

    * condition worsens
    * symptoms last more than 7 days

Inactive Ingredient

Shea butter (butyrospermum parkii), aloe barbadensis gel, cocoa (theobroma cacao) butter, beeswax, potato (solanium tuberosum) starch, cetearyl alcohol, grape (vitis vinifera) seed oil, kaolin, sesame (sesamum indicum) oil, titanium dioxide, phenoxyethanol, licorice (glycyrrhiza glabra) root extract, calendula officinalis seed oil, Unisooth EG-28 (water  propyl gallate  gallyl glucoside  epigallocatechin gallatyl glucoside), glyceryl caprylate, olive (olea europaea) oil*, glycerin, chamomile (anthemis nobilis ) extract, benzoic acid, dehydroacetic acid, borage (borago officinalis) seed oil, evening primrose (oenothera biennis) oil, fragrance, lavender (lavandula angustifolia) extract.

* Please review the disclaimer below.