Ab0028 Em Foaming

Ab0028 Em Foaming
SPL v1
SPL
SPL Set ID ab86658c-d4c2-4d3e-a832-a10a0f628abb
Route
TOPICAL
Published
Effective Date 2020-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Sodium Lauroamphoacetate Cocamidopropylamine Oxide Water Fd&c Blue No. 1 Cocamidopropyl Betaine Glycerin Olea Europaea Leaf Cetylpyridinium Chloride Citric Acid Monohydrate Disodium Hedta Benzophenone Methylchloroisothiazolinone Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-31

Description

Benzalkonium Chloride 0.13%


Medication Information

Description

Benzalkonium Chloride 0.13%

Use

Hand sanitizer to help reduce bacteria on skin that could cause disease

Recommended for repeated use

Section 51945-4

Section 55105-1

Purpose: 

Antibacterial

Warnings

For external use on hands only.

Directions
  • Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product
Other Information

To prevent discoloration, avoid contact with clothing

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients

Water, Sodium lauroamphoacetate, Cocamidopropylamine oxide, Cocamidopropyl betaine, Glycerin, Olea europaea (olive) leaf extract, Polyminopropyl biguanide, Citric acid, Disodium EDTA, Benzophenone-3, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Cetylpyridinium chloride,  Blue 1 (CI42090)

When Using This Product

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water

Do not ingest or inhale

Avoid contact with broken skin

Stop Use and Ask A Doctor

if irrigation and redness develop or if condition persists for more than 72 hours

Keep Out of Reach of Children

if swallowed, get medical help or contact a Poison Control Center immediately


Structured Label Content

Use

Hand sanitizer to help reduce bacteria on skin that could cause disease

Recommended for repeated use

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: 

Antibacterial

Warnings

For external use on hands only.

Directions
  • Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product
Other Information (Other information)

To prevent discoloration, avoid contact with clothing

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water, Sodium lauroamphoacetate, Cocamidopropylamine oxide, Cocamidopropyl betaine, Glycerin, Olea europaea (olive) leaf extract, Polyminopropyl biguanide, Citric acid, Disodium EDTA, Benzophenone-3, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Cetylpyridinium chloride,  Blue 1 (CI42090)

When Using This Product (When using this product)

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water

Do not ingest or inhale

Avoid contact with broken skin

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irrigation and redness develop or if condition persists for more than 72 hours

Keep Out of Reach of Children (Keep out of reach of children)

if swallowed, get medical help or contact a Poison Control Center immediately


Advanced Ingredient Data


Raw Label Data

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