drug facts

drug facts
SPL v1
SPL
SPL Set ID 32aa0e9b-cf69-4cee-a19f-0329309e19d3
Route
topical
Published
Effective Date 2014-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
water cocamidopropyl betaine hypromelloses glycerin decyl glucoside aloe vera leaf poloxamer 124 polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) edetate sodium citric acid monohydrate sodium citrate methylchloroisothiazolinone methylisothiazolinone ext. d&c violet no. 2

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2014-04-22

Purpose

ANTIBACTERIAL

Description

BENZALKONIUM CHLORIDE 0.13%


Medication Information

Warnings

FOR EXTERNAL USE ONLY

Uses

HELPS ELIMINATE BACTERIA ON HANDS

Purpose

ANTIBACTERIAL

Directions

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

Other Information

STORE AT ROOM TEMPERATURE

Inactive Ingredients

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

Description

BENZALKONIUM CHLORIDE 0.13%

Label Copy

Active Ingredient

BENZALKONIUM CHLORIDE 0.13%

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

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Uses (USES)

HELPS ELIMINATE BACTERIA ON HANDS

Purpose (PURPOSE)

ANTIBACTERIAL

Directions (DIRECTIONS)

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

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

BENZALKONIUM CHLORIDE 0.13%

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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