Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID abe721b1-f24d-4a5f-8ba2-55a7daeeca2e
Route
TOPICAL
Published
Effective Date 2014-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-05-07

Description

BENZALKONIUM CHLORIDE 0.13%

Purpose

ANTIBACTERIAL


Medication Information

Purpose

ANTIBACTERIAL

Description

BENZALKONIUM CHLORIDE 0.13%

Uses

HELPS REDUCE BACTERIA ON THE SKIN

Warnings

FOR EXTERNAL USE ONLY

Directions

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

Label Copy

Active Ingredient

BENZALKONIUM CHLORIDE 0.13%

Other Information

STORE AT ROOM TEMPERATURE

Inactive Ingredients

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

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 A Doctor If

IRRITATION AND REDNESS DEVELOPS AND LASTS


Structured Label Content

Uses (USES)

HELPS REDUCE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTIBACTERIAL

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

APPLY ONTO WET HANDS. WORK INTO LATHER, 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)

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

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

IRRITATION AND REDNESS DEVELOPS AND LASTS


Advanced Ingredient Data


Raw Label Data

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