Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ebc38725-4303-4e1f-a794-ee0550af967b
Route
TOPICAL
Published
Effective Date 2014-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Fd&c Blue No. 1 Green Tea Leaf Cetrimonium Chloride Citric Acid Monohydrate Tangerine Peel Coco Monoethanolamide Glycerin Lauramidopropylamine Oxide Methylchloroisothiazolinone Methylisothiazolinone Peg-120 Methyl Glucose Dioleate Sodium Chloride Sodium Sulfate Edetate Sodium Water Fd&c Yellow No. 5 Ginger

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-01-13

Description

BENZALKONIUM CHLORIDE 0.13%

Purpose

ANTIBACTERIAL


Medication Information

Purpose

ANTIBACTERIAL

Description

BENZALKONIUM CHLORIDE 0.13%

Uses

HELPS ELIMINATE BACTERIA ON HANDS

Warnings

FOR EXTERNAL USE ONLY

Directions

APPLY ONTO WET HANDS. LATHER AND RINSE THOROUGHLY

Label Copy

Active Ingredient

BENZALKONIUM CHLORIDE 0.13%

Other Information

STORE AT ROOM TEMPERATURE

Inactive Ingredients

BLUE 1 (CI 42090), CAMELLIA SINENSIS LEAF EXTRACT, CETRIMONIUM CHLORIDE, CITRIC ACID, CITRUS NOBILIS (MANDARIN ORANGE) PEEL EXTRACT, COCAMIDE MEA, FRAGRANCE (PARFUM), GLYCERIN, LAURYL/MYRISTYL AMIDOPROPYL AMINE OXIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, PEG-120 METHYL GLUCOSE DIOLEATE, SODIUM CHLORIDE, SODIUM SULFATE, TETRASODIUM EDTA, WATER (AQUA), YELLOW 5 (CI 19140), ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Stop Using This Product and Ask A Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS


Structured Label Content

Uses (USES)

HELPS ELIMINATE BACTERIA ON HANDS

Purpose (PURPOSE)

ANTIBACTERIAL

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

APPLY ONTO WET HANDS. LATHER AND RINSE THOROUGHLY

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

BENZALKONIUM CHLORIDE 0.13%

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE

Inactive Ingredients (INACTIVE INGREDIENTS)

BLUE 1 (CI 42090), CAMELLIA SINENSIS LEAF EXTRACT, CETRIMONIUM CHLORIDE, CITRIC ACID, CITRUS NOBILIS (MANDARIN ORANGE) PEEL EXTRACT, COCAMIDE MEA, FRAGRANCE (PARFUM), GLYCERIN, LAURYL/MYRISTYL AMIDOPROPYL AMINE OXIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, PEG-120 METHYL GLUCOSE DIOLEATE, SODIUM CHLORIDE, SODIUM SULFATE, TETRASODIUM EDTA, WATER (AQUA), YELLOW 5 (CI 19140), ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Stop Using This Product and Ask A Doctor If (STOP USING THIS PRODUCT AND ASK A DOCTOR IF)

IRRITATION OR REDNESS DEVELOPS AND LASTS


Advanced Ingredient Data


Raw Label Data

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