drug facts

drug facts
SPL v1
SPL
SPL Set ID 5934b933-64fd-47b7-a874-3a343679055f
Route
topical
Published
Effective Date 2014-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 mg)
Inactive Ingredients
water cocamidopropyl betaine glycerin decyl glucoside hydroxyethyl cellulose (5000 cps at 1%) aloe vera leaf poloxamer 124 polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) edetate sodium citric acid monohydrate sodium citrate green tea leaf saccharomyces lysate .alpha.-tocopherol acetate vitamin a palmitate ascorbyl palmitate niacinamide methylchloroisothiazolinone methylisothiazolinone fd&c blue no. 1 d&c red no. 33

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2014-04-09

Purpose

ANTIBACTERIAL

Description

BENZALKONIUM CHLORIDE 0.13%


Medication Information

Warnings

FOR EXTERNAL USE ONLY.

Uses

HELPS ELIMINATE BACTERIA ON HANDS.

Purpose

ANTIBACTERIAL

Directions

APPLY ONTO WET HANDS. LATHER AND RINSE THOROUGHLY.

Other Information

STORE AT ROOM TEMPERATURE.

Inactive Ingredients

WATER (AQUA), COCAMIDOPROPYL BETAINE, GLYCERIN, DECYL GLUCOSIDE, HYDROXYETHYLCELLULOSE, ALOE BARBADENSIS LEAF JUICE, FRAGRANCE (PARFUM), POLOXAMER 124, POLYQUATERNIUM-7, TETRASODIUM EDTA, CITRIC ACID, SODIUM CITRATE, CAMELLIA SINENSIS LEAF EXTRACT, SACCHAROMYCES FERMENT, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, NIACINAMIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), RED 33 (CI 17200). 

Description

BENZALKONIUM CHLORIDE 0.13%

Label Image

Active Ingredient

BENZALKONIUM CHLORIDE 0.13%

Questions Or Comments?

1-800-934-1204

When Using This Product

AVOID CONTACT ITH EYES. IN CASE OF CONTACT, RINSE WITH WATER.

Stop Use and Ask A Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS.

Keep Out of Reach of Children

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


Structured Label Content

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Uses (USES)

HELPS ELIMINATE BACTERIA ON HANDS.

Purpose (PURPOSE)

ANTIBACTERIAL

Directions (DIRECTIONS)

APPLY ONTO WET HANDS. LATHER AND RINSE THOROUGHLY.

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE.

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), COCAMIDOPROPYL BETAINE, GLYCERIN, DECYL GLUCOSIDE, HYDROXYETHYLCELLULOSE, ALOE BARBADENSIS LEAF JUICE, FRAGRANCE (PARFUM), POLOXAMER 124, POLYQUATERNIUM-7, TETRASODIUM EDTA, CITRIC ACID, SODIUM CITRATE, CAMELLIA SINENSIS LEAF EXTRACT, SACCHAROMYCES FERMENT, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, NIACINAMIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), RED 33 (CI 17200). 

Label Image (LABEL IMAGE)

Active Ingredient (ACTIVE INGREDIENT)

BENZALKONIUM CHLORIDE 0.13%

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-934-1204

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT ITH EYES. IN CASE OF CONTACT, RINSE WITH WATER.

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

IRRITATION OR REDNESS DEVELOPS AND LASTS.

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.


Advanced Ingredient Data


Raw Label Data

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