Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 44312ad9-bdb0-4258-95cc-ad8d0db6754c
Route
TOPICAL
Published
Effective Date 2014-07-29
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 Sodium Citrate Xanthan Gum Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Decyl Glucoside Edetate Sodium Citric Acid Monohydrate Green Tea Leaf Aloe Vera Leaf Methylchloroisothiazolinone Methylisothiazolinone Fd&c Red No. 4 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-07-28

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

USE ONLY TO REFILL A FOAMING HAND SOAP PUMP BOTTLE. 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, POLYSORBATE 20, GLYCERIN, FRAGRANCE (PARFUM), SODIUM CITRATE, XANTHAN GUM, POLYQUATERNIUM-7, DECYL GLUCOSIDE, TETRASODIUM EDTA, CITRIC ACID, CAMELLIA SINENSIS LEAF EXTRACT, ALOE BARBADENSIS LEAF JUICE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 4 (CI 124700), YELLOW 5 (CI 19140)

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 A Doctor If

IRRITATION AND REDNESS DEVELOP AND LAST


Structured Label Content

Uses (USES)

HELPS ELIMINATE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTIBACTERIAL

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

USE ONLY TO REFILL A FOAMING HAND SOAP PUMP BOTTLE. 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, POLYSORBATE 20, GLYCERIN, FRAGRANCE (PARFUM), SODIUM CITRATE, XANTHAN GUM, POLYQUATERNIUM-7, DECYL GLUCOSIDE, TETRASODIUM EDTA, CITRIC ACID, CAMELLIA SINENSIS LEAF EXTRACT, ALOE BARBADENSIS LEAF JUICE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 4 (CI 124700), YELLOW 5 (CI 19140)

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 A Doctor If (STOP USING THIS PRODUCT AND ASK A DOCTOR IF)

IRRITATION AND REDNESS DEVELOP AND LAST


Advanced Ingredient Data


Raw Label Data

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