Xtracare With Cooling Action Oatmeal Skin Relief Calmin

Xtracare With Cooling Action Oatmeal Skin Relief Calmin
SPL v2
SPL
SPL Set ID a6dfaef5-8e98-4575-9f46-1e27e28fbac0
Route
TOPICAL
Published
Effective Date 2014-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (3 g)
Inactive Ingredients
Water Mineral Oil Petrolatum Glycerin Glyceryl Monostearate Propylene Glycol Peg-100 Stearate Polyacrylamide (1500 Mw) Cetyl Alcohol Oat Dmdm Hydantoin Stearyl Alcohol C13-14 Isoparaffin Laureth-7 Edetate Disodium Menthol Aloe Vera Leaf Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-11-26

Description

Active Ingredient                     Purpose Dimethicone 1/3% ......... Skin Protectant


Medication Information

Warnings and Precautions

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.

Indications and Usage

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

Dosage and Administration

Directions   apply liberally as often as needed.

Description

Active Ingredient                     Purpose Dimethicone 1/3% ......... 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, 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.

Section 51945-4

Section 55105-1

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)

Section 55106-9

Active Ingredient                     Purpose

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

Section 60561-8

Other Information   store at room temperature.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC.

48325 BINGHAMPTON DR.,

NORTHVILLE, MI 48168 USA

MADE IN CHINA


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions   apply liberally as often as needed.

Warnings and Precautions (34071-1)

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.

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, 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.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

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)

Section 55106-9 (55106-9)

Active Ingredient                     Purpose

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

Section 60561-8 (60561-8)

Other Information   store at room temperature.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC.

48325 BINGHAMPTON DR.,

NORTHVILLE, MI 48168 USA

MADE IN CHINA


Advanced Ingredient Data


Raw Label Data

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