drug facts

drug facts
SPL v1
SPL
SPL Set ID 9d9f71c2-0976-4b14-94fa-8312e65eb941
Route
topical
Published
Effective Date 2015-07-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
water cetrimonium chloride glycerin lauramidopropylamine oxide coco monoethanolamide sodium chloride peg-120 methyl glucose dioleate citric acid monohydrate edetate sodium sodium sulfate methylchloroisothiazolinone methylisothiazolinone fd&c red no. 40 fd&c yellow no. 5 d&c red no. 33

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2015-07-01

Purpose

ANTIBACTERIAL

Description

BENZALKONIUM CHLORIDE 0.13%


Medication Information

Warnings

FOR EXTERNAL USE ONLY

Uses

HELPS ELIMINATE BACTERIA ON HANDS

Purpose

ANTIBACTERIAL

Directions
  • APPLY ONTO WET HANDS
  • LATHER AND RINSE THOROUGHLY
Other Information

STORE AT ROOM TEMPERATURE

Inactive Ingredients

WATER (AQUA), CETRIMONIUM CHLORIDE, GLYCERIN, LAURYL/MYRISTYL AMIDOPROPYL AMINE OXIDE, COCAMIDE MEA, SODIUM CHLORIDE, PEG-120 METHYL GLUCOSE DIOLEATE, FRAGRANCE (PARFUM), CITRIC ACID, TETRASODIUM EDTA, SODIUM SULFATE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 40 (CI 16035), YELLOW 5 (CI 19140), RED 33 (CI 17200)

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 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

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Uses (USES)

HELPS ELIMINATE BACTERIA ON HANDS

Purpose (PURPOSE)

ANTIBACTERIAL

Directions (DIRECTIONS)
  • APPLY ONTO WET HANDS
  • LATHER AND RINSE THOROUGHLY
Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), CETRIMONIUM CHLORIDE, GLYCERIN, LAURYL/MYRISTYL AMIDOPROPYL AMINE OXIDE, COCAMIDE MEA, SODIUM CHLORIDE, PEG-120 METHYL GLUCOSE DIOLEATE, FRAGRANCE (PARFUM), CITRIC ACID, TETRASODIUM EDTA, SODIUM SULFATE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 40 (CI 16035), YELLOW 5 (CI 19140), RED 33 (CI 17200)

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 THOROUGHLY WITH WATER

Stop Use and Ask A Doctor (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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