drug facts

drug facts
SPL v1
SPL
SPL Set ID a63f75d6-ed5d-4d13-b75f-32309981e774
Route
topical
Published
Effective Date 2014-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
aloe vera leaf fd&c blue no. 1 green tea leaf citric acid monohydrate cocamidopropyl betaine decyl glucoside ext. d&c violet no. 2 glycerin methylchloroisothiazolinone methylisothiazolinone polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) polysorbate 20 sodium citrate edetate sodium water xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2014-02-25

Purpose

ANTIBACTERIAL

Description

BENZALKONIUM CHLORIDE 0.13%


Medication Information

Warnings

FOR EXTERNAL USE ONLY

Uses

FOR WASHING TO DECREASE BACTERIA ON THE SKIN

Purpose

ANTIBACTERIAL

Directions

APPLY ONTO DRY HANDS, WORK INTO A RICH FOAMY LATHER AND RINSE AND DRY THOROUGHLY

Other Information

STORE AT ROOM TEMPERATURE

Inactive Ingredients

ALOE BARBADENSIS LEAF JUICE, BLUE 1 (CI 42090), CAMELLIA SINENSIS LEAF EXTRACT, CITRIC ACID, COCAMIDOPROPYL BETAINE, DECYL GLUCOSIDE, EXT. VIOLET 2 (CI 60730), FRAGRANCE (PARFUM), GLYCERIN, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, POLYQUATERNIUM-7, POLYSORBATE 20, SODIUM CITRATE, TETRASODIUM EDTA, WATER (AQUA), XANTHAN GUM

Description

BENZALKONIUM CHLORIDE 0.13%

Label Copy

Active Ingredient

BENZALKONIUM CHLORIDE 0.13%

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGH 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)

FOR WASHING TO DECREASE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTIBACTERIAL

Directions (DIRECTIONS)

APPLY ONTO DRY HANDS, WORK INTO A RICH FOAMY LATHER AND RINSE AND DRY THOROUGHLY

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE

Inactive Ingredients (INACTIVE INGREDIENTS)

ALOE BARBADENSIS LEAF JUICE, BLUE 1 (CI 42090), CAMELLIA SINENSIS LEAF EXTRACT, CITRIC ACID, COCAMIDOPROPYL BETAINE, DECYL GLUCOSIDE, EXT. VIOLET 2 (CI 60730), FRAGRANCE (PARFUM), GLYCERIN, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, POLYQUATERNIUM-7, POLYSORBATE 20, SODIUM CITRATE, TETRASODIUM EDTA, WATER (AQUA), XANTHAN GUM

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

BENZALKONIUM CHLORIDE 0.13%

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGH 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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