Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 256b9740-3046-4f5c-81e2-87ba69438e6a
Route
TOPICAL
Published
Effective Date 2013-10-21
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 2013-10-18

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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