Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 28b6356d-e9fb-4cf3-8490-2d089f5b3fad
Route
TOPICAL
Published
Effective Date 2013-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Cocamidopropyl Betaine Glycerin Decyl Glucoside Aloe Vera Leaf Green Tea Leaf Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Xanthan Gum Edetate Sodium Polysorbate 20 Sodium Citrate Citric Acid Monohydrate Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 D&c Violet No. 2

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-10-30

Description

BENZALKONIUM CHLORIDE 0.13%

Purpose

ANTIBACTERIAL


Medication Information

Purpose

ANTIBACTERIAL

Description

BENZALKONIUM CHLORIDE 0.13%

Uses

HELPS ELIMINATE BACTERIA ON THE SKIN

Warnings

FOR EXTERNAL USE ONLY

Directions

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

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES 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 Doctor If

IRRITATION AND REDNESS DEVELOPS AND LASTS


Structured Label Content

Uses (USES)

HELPS ELIMINATE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTIBACTERIAL

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

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

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES 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 Doctor If (STOP USING THIS PRODUCT AND ASK DOCTOR IF)

IRRITATION AND REDNESS DEVELOPS AND LASTS


Advanced Ingredient Data


Raw Label Data

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