Otc - Active Ingredient
Active Ingredient Purpose
Dimethicone 1.2% ............................ Skin Protectant
Baby Xtracare Oatmeal
FDA Label NDC 58503-070
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by China Ningbo Shangge Cosmetic Technology Corp for the product Baby Xtracare Oatmeal (NDC 58503-070). 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, dosage & administration, warnings, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use
Help prevent and temporarily protects chafed, chapped, or cracked skin.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Indications & Usage
Baby XtraCare®
Oatmeal Daily Moisturizing Lotion
Lightly Scented
Dimethicon Skin Protectant with Natural Oat Extract
Helps Soothe & Soften Baby's Skin
12 FL OZ (354 mL)
Dosage & Administration
Directions
Apply liberally as often as needed.
Warnings
Warnings
For extenal use only.
When using this product avoid contact with eyes. In case of eye contact, flush with water.
Stop use and ask a doctor if condition worsens. Symptoms last more than 7days or clear up and occur again within a few days.
Inactive Ingredient
Inactive Ingredients
water, petrolatum, mineral oil, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa (oatmeal) kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, aloe barbadensis leaf juice, methylparaben, propylparaben.
Other Safety Information
Other Information Store at room temperature.
Questions/Comments? 1-855-345-5575
DISTRIBUTED BY
REJOICE INTERNATIONAL INC
NORTHVILLE, MI 48168 U.S.A.
MADE IN CHINA
Package Label.Principal Display Panel
* Please review the disclaimer below.
