Otc - Active Ingredient
Active Ingredient Purpose
Dimethicone 1/3% ......... Skin Protectant
Xtracare With Cooling Action Oatmeal Skin Relief Calmin Lotion
FDA Label NDC 57337-038
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International for the product Xtracare With Cooling Action Oatmeal Skin Relief Calmin (NDC 57337-038). 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, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
XtraCare (with cooling action) Oatmeal Skin Relief Calming Lotion
dimethicone skin protectant
with natural colloidal oatmeal
provides immediate and lasting moisture relief for itchy, extra dry skin
12 fl oz (354 mL)
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
Use Help prevent and temporarily protects chafed, chapped, or cracked skin.
Warnings
Warnings For external 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 7 days or clear up and occur again within a few days.
Dosage & Administration
Directions apply liberally as often as needed.
Other Safety Information
Other Information store at room temperature.
DISTRIBUTED BY:
REJOICE INTERNATIONAL INC.
48325 BINGHAMPTON DR.,
NORTHVILLE, MI 48168 USA
MADE IN CHINA
Inactive Ingredient
Inactive Ingredients
water, paraffinum liquidum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, menthol, aloe barbadensis leaf juice, methylparaben, propylparaben.
Package Label.Principal Display Panel
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