SPL v2
SPL
SPL Set ID 0049462b-ff31-440f-9244-b61153625bca
Route
TOPICAL
Published
Effective Date 2015-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (1.2 g)
Inactive Ingredients
Water Petrolatum Mineral Oil Glycerin Glyceryl Monostearate Propylene Glycol Peg-100 Stearate Polyacrylamide (10000 Mw) Cetyl Alcohol Avena Sativa Whole Dmdm Hydantoin Stearyl Alcohol C13-14 Isoparaffin Laureth-7 Edetate Disodium Aloe Vera Leaf Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-02-16

Description

Active Ingredient                                      Purpose Dimethicone 1.2% ............................ Skin Protectant


Medication Information

Warnings and Precautions

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.

Indications and 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 and Administration

Directions

Apply liberally as often as needed.

Description

Active Ingredient                                      Purpose Dimethicone 1.2% ............................ Skin Protectant

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6

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.

Section 51945-4

Section 55105-1

Use

Help prevent and temporarily protects chafed, chapped, or cracked skin.

Section 55106-9

Active Ingredient                                      Purpose

Dimethicone 1.2% ............................ Skin Protectant

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

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 and Administration (34068-7)

Directions

Apply liberally as often as needed.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Use

Help prevent and temporarily protects chafed, chapped, or cracked skin.

Section 55106-9 (55106-9)

Active Ingredient                                      Purpose

Dimethicone 1.2% ............................ Skin Protectant

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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