Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 59c0028b-82be-4513-8cd6-c7655fc93e89
Route
TOPICAL
Published
Effective Date 2014-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-06-16

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

PUMP ONTO DRY HANDS. WORK INTO A RICH FOAMY LATER, RINSE THOROUGHLY AND DRY

Label Copy

Active Ingredient

BENZALKONIUM CHLORIDE 0.13%

Other Information

STORE AT ROOM TEMPERATURE

Inactive Ingredients

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

When Using This Product

AVOID CONTACT WITH EYES. IN CASE OF CONTACT, RINSE 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 OR REDNESS DEVELOP AND LAST


Structured Label Content

Uses (USES)

HELPS ELIMINATE BACTERIA ON HANDS

Purpose (PURPOSE)

ANTIBACTERIAL

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

PUMP ONTO DRY HANDS. WORK INTO A RICH FOAMY LATER, RINSE THOROUGHLY AND DRY

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

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IN CASE OF CONTACT, RINSE 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 OR REDNESS DEVELOP AND LAST


Advanced Ingredient Data


Raw Label Data

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