Xtracare Antibacterial Hand Cleanse

Xtracare Antibacterial Hand Cleanse
SPL v5
SPL
SPL Set ID c31723d5-a313-448a-8b69-ca5f8dec25ed
Route
TOPICAL
Published
Effective Date 2013-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triclosan (3.3 mg)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Sodium Laureth Sulfate Coco Diethanolamide Sodium Chloride Peg-150 Distearate Citric Acid Monohydrate Glycerin Edetate Disodium Aloe Vera Leaf Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-09-03

Description

Active Ingredient                                     Purpose Triclosan 0.15%...................................Antibacterial


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 irritation and redness develops.

Indications and Usage

Antibacterial Moisturizing Hand Soap

Mountain Spring Scent

  • Kills the germs
  • Eliminates bacteria on hands
  • Moisturizes the skin

Dosage and Administration

Directions

  • pump into hands
  • lather vigorously for at least 15 seconds
  • rinse and dry thoroughly.
Description

Active Ingredient                                     Purpose Triclosan 0.15%...................................Antibacterial

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, sodium laureth sulfate, cocamide DEA, sodium chloride, PEG-150 distearate, fragrance, citric acid, glycerin, disodium EDTA, aloe barbadensis leaf juice, methylchloroisothiazolinone, methylisothiazolinone, fd&c blue no. 1.

Section 51945-4

Section 55105-1

Uses

for hand washing to decrease bacteria on the skin.

Section 55106-9

Active Ingredient                                     Purpose

Triclosan 0.15%...................................Antibacterial

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)

Antibacterial Moisturizing Hand Soap

Mountain Spring Scent

  • Kills the germs
  • Eliminates bacteria on hands
  • Moisturizes the skin

Dosage and Administration (34068-7)

Directions

  • pump into hands
  • lather vigorously for at least 15 seconds
  • rinse and dry thoroughly.
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 irritation and redness develops.

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, sodium laureth sulfate, cocamide DEA, sodium chloride, PEG-150 distearate, fragrance, citric acid, glycerin, disodium EDTA, aloe barbadensis leaf juice, methylchloroisothiazolinone, methylisothiazolinone, fd&c blue no. 1.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

for hand washing to decrease bacteria on the skin.

Section 55106-9 (55106-9)

Active Ingredient                                     Purpose

Triclosan 0.15%...................................Antibacterial

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


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