Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2f7e4e9f-6d38-42f8-afad-ca3e86fae1bf
Route
TOPICAL
Published
Effective Date 2014-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Cocamidopropyl Betaine Hydroxyethyl Cellulose (5000 Cps At 1%) Glycerin Decyl Glucoside Aloe Vera Leaf Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Poloxamer 124 Edetate Sodium Sodium Citrate Citric Acid Monohydrate Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 Ext. D&c Violet No. 2

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-08-17

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 A SMALL AMOUNT ONTO WET HANDS. WORK INTO A LATHER AND RINSE THOROUGHLY

Label Copy

Active Ingredient

BENZALKONIUM CHLORIDE 0.13%

Other Information

STORE AT ROOM TEMPERATURE

Inactive Ingredients

WATER (AQUA), COCAMIDOPROPYL BETAINE, HYDROXYETHYLCELLULOSE, GLYCERIN, DECYL GLUCOSIDE, ALOE BARBADENSIS LEAF JUICE, FRAGRANCE (PARFUM), POLYQUATERNIUM-7, POLOXAMER 124, TETRASODIUM EDTA, SODIUM CITRATE, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), EXT. VIOLET 2 (CI 60730)

Questions Or Comments?

1-888-287-1915

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH 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 A SMALL AMOUNT ONTO WET HANDS. WORK INTO A 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)

WATER (AQUA), COCAMIDOPROPYL BETAINE, HYDROXYETHYLCELLULOSE, GLYCERIN, DECYL GLUCOSIDE, ALOE BARBADENSIS LEAF JUICE, FRAGRANCE (PARFUM), POLYQUATERNIUM-7, POLOXAMER 124, TETRASODIUM EDTA, SODIUM CITRATE, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), EXT. VIOLET 2 (CI 60730)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-888-287-1915

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH 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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