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  5. Label Information: Xtracare With Cooling Action Oatmeal Skin Relief Calmin

FDA Label for Xtracare With Cooling Action Oatmeal Skin Relief Calmin

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. OTHER SAFETY INFORMATION
    8. INACTIVE INGREDIENT
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Xtracare With Cooling Action Oatmeal Skin Relief Calmin Product Label

The following document was submitted to the FDA by the labeler of this product Rejoice International. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient                     Purpose

Dimethicone 1/3% ......... Skin Protectant


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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