Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID fb689107-8847-4dd1-b703-90cc2066763a
Route
TOPICAL
Published
Effective Date 2014-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Aloe Vera Leaf Green Tea Leaf Citric Acid Acetate Cocamidopropyl Betaine Decyl Glucoside Glycerin Fd&c Green No. 3 Methylchloroisothiazolinone Methylisothiazolinone Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Polysorbate 20 Sodium Citrate Edetate Sodium Water Xanthan Gum D&c Yellow No. 10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-01-26

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

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

Label Copy

Active Ingredient

BENZALKONIUM CHLORIDE 0.13%

Other Information

STORE AT ROOM TEMPERATURE

Inactive Ingredients

ALOE BARBADENSIS LEAF JUICE, CAMELLIA SINENSIS LEAF EXTRACT, CITRIC ACID, COCAMIDOPROPYL BETAINE, DECYL GLUCOSIDE, FRAGRANCE (PARFUM), GLYCERIN, GREEN 3 (CI 42053), METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, POLYQUATERNIUM-7, POLYSORBATE 20, SODIUM CITRATE, TETRASODIUM EDTA, WATER (AQUA), XANTHAN GUM, YELLOW 10 (CI 47005)

Questions Or Comments?

1-800-746-7287

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY 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

Uses (USES)

FOR WASHING TO DECREASE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTIBACTERIAL

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

APPLY ONTO DRY HANDS. WORK INTO A LATHER, RINSE AND DRY 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)

ALOE BARBADENSIS LEAF JUICE, CAMELLIA SINENSIS LEAF EXTRACT, CITRIC ACID, COCAMIDOPROPYL BETAINE, DECYL GLUCOSIDE, FRAGRANCE (PARFUM), GLYCERIN, GREEN 3 (CI 42053), METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, POLYQUATERNIUM-7, POLYSORBATE 20, SODIUM CITRATE, TETRASODIUM EDTA, WATER (AQUA), XANTHAN GUM, YELLOW 10 (CI 47005)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-746-7287

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY 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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