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  5. Label Information: Baby Xtracare Oatmeal

FDA Label for Baby Xtracare Oatmeal

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. DOSAGE & ADMINISTRATION
    6. WARNINGS
    7. INACTIVE INGREDIENT
    8. OTHER SAFETY INFORMATION
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Baby Xtracare Oatmeal 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 1.2% ............................ Skin Protectant


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




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