Xtracare Foaming Facial Cleanser

Xtracare Foaming Facial Cleanser
SPL v2
SPL
SPL Set ID 5b78fe93-31be-4bfe-88dd-cd310b9ba1f7
Route
TOPICAL
Published
Effective Date 2013-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triclosan (1 mg)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Cocamidopropyl Betaine Polyoxyl 40 Castor Oil Dmdm Hydantoin Edetate Disodium Citric Acid Monohydrate Methylparaben Propylparaben Fd&c Yellow No. 5 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-11-26

Description

Active Ingredient                          Purpose Triclosan 0.25% ........................... Antiseptic


Medication Information

Warnings and Precautions

Warnings For external use only

When using this product avoid contact with eyes.  if eye contact occurs, immediately flush with water.

Stop use and ask a doctor if

  • excessive skin irritation develops or condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Indications and Usage

Use  to help reduce bacteria on the skin

Dosage and Administration

Directions

mix in hands with water. Work into a foamy later. Smooth over face and neck. Rinse thoroughly.

Description

Active Ingredient                          Purpose Triclosan 0.25% ........................... Antiseptic

Section 50565-1

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients

water, sodium c14-16 olefin sulfonate, cocamide betaine, glycerin, PEG-40 hydrogenated castor oil, fragrance, DMDM hydantoin, disodium EDTA, citric acid, methylparaben, propylparaben, fd&c yellow no.5, d&c red no.33

Section 51945-4

Section 55105-1

XtraCare (oil-free) foaming facial cleanser

medicated to kill problem-causing bacteria without overdrying

Compare to Clean & Clear® Foaming Facial Cleanser

8 fl. oz. (237 mL)

oil free foaming facial cleanser

Section 55106-9

Active Ingredient                          Purpose

Triclosan 0.25% ........................... Antiseptic

Section 60561-8

Other Information

Do not store where water may enter bottle.

*This product is not manufactured or distributed by Johnson&Johnson, the distributor of clean&clear®foaming facial cleanser.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC.

NORTHVILLE, MI 48168 USA

MADE IN CHINA


Structured Label Content

Indications and Usage (34067-9)

Use  to help reduce bacteria on the skin

Dosage and Administration (34068-7)

Directions

mix in hands with water. Work into a foamy later. Smooth over face and neck. Rinse thoroughly.

Warnings and Precautions (34071-1)

Warnings For external use only

When using this product avoid contact with eyes.  if eye contact occurs, immediately flush with water.

Stop use and ask a doctor if

  • excessive skin irritation develops or 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 right away.

Section 51727-6 (51727-6)

Inactive Ingredients

water, sodium c14-16 olefin sulfonate, cocamide betaine, glycerin, PEG-40 hydrogenated castor oil, fragrance, DMDM hydantoin, disodium EDTA, citric acid, methylparaben, propylparaben, fd&c yellow no.5, d&c red no.33

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

XtraCare (oil-free) foaming facial cleanser

medicated to kill problem-causing bacteria without overdrying

Compare to Clean & Clear® Foaming Facial Cleanser

8 fl. oz. (237 mL)

oil free foaming facial cleanser

Section 55106-9 (55106-9)

Active Ingredient                          Purpose

Triclosan 0.25% ........................... Antiseptic

Section 60561-8 (60561-8)

Other Information

Do not store where water may enter bottle.

*This product is not manufactured or distributed by Johnson&Johnson, the distributor of clean&clear®foaming facial cleanser.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC.

NORTHVILLE, MI 48168 USA

MADE IN CHINA


Advanced Ingredient Data


Raw Label Data

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