Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 80274829-29ad-4403-9696-3afdee8a57b3
Route
TOPICAL
Published
Effective Date 2014-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Cocamidopropyl Betaine Decyl Glucoside Hydroxyethyl Cellulose (5000 Cps At 1%) Glycerin Citric Acid Monohydrate Poloxamer 124 Edetate Sodium Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Sodium Citrate Aloe Vera Leaf Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 Ext. D&c Violet No. 2

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-03-05

Description

BENZALKONIUM CHLORIDE 0.13%

Purpose

ANTIBACTERIAL


Medication Information

Purpose

ANTIBACTERIAL

Description

BENZALKONIUM CHLORIDE 0.13%

Uses

FOR WASHING TO DECREASE BACTERIA ON THE SKIN

Warnings

FOR EXTERNAL USE ONLY

Directions

SQUEEZE A SMALL AMOUNT ONTO A WET WASHCLOTH, SPONGE, POUF OR HANDS AND APPLY TO BODY. WORK INTO A RICH LATHER AND RINSE OFF

Label Copy

Active Ingredient

BENZALKONIUM CHLORIDE 0.13%

Other Information

STORE AT ROOM TEMPERATURE

Inactive Ingredients

WATER (AQUA), COCAMIDOPROPYL BETAINE, DECYL GLUCOSIDE, HYDROXYETHYLCELLULOSE, GLYCERIN, CITRIC ACID, POLOXAMER 124, FRAGRANCE (PARFUM), TETRASODIUM EDTA, POLYQUATERNIUM-7, SODIUM CITRATE, ALOE BARBADENSIS LEAF JUICE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), EXT. VIOLET 2 (CI 60730)

Questions Or Comments?

1-800-910-6874

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, 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 AND REDNESS DEVELOPS


Structured Label Content

Uses (USES)

FOR WASHING TO DECREASE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTIBACTERIAL

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

SQUEEZE A SMALL AMOUNT ONTO A WET WASHCLOTH, SPONGE, POUF OR HANDS AND APPLY TO BODY. WORK INTO A RICH LATHER AND RINSE OFF

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, DECYL GLUCOSIDE, HYDROXYETHYLCELLULOSE, GLYCERIN, CITRIC ACID, POLOXAMER 124, FRAGRANCE (PARFUM), TETRASODIUM EDTA, POLYQUATERNIUM-7, SODIUM CITRATE, ALOE BARBADENSIS LEAF JUICE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), EXT. VIOLET 2 (CI 60730)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-910-6874

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, 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 AND REDNESS DEVELOPS


Advanced Ingredient Data


Raw Label Data

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