77731-087/ab0054lz-yel Foaming

77731-087/ab0054lz-yel Foaming
SPL v1
SPL
SPL Set ID c3307c6e-4766-47f7-8710-63d2facf33db
Route
TOPICAL
Published
Effective Date 2020-09-17
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 Yellow No. 5 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 2020-09-17

Description

Benzalkonium Chloride 0.13%


Medication Information

Description

Benzalkonium Chloride 0.13%

Use

Decreases bacteria on skin that could cause diseases

Recommended for repeated use

Section 51945-4

Section 55105-1

Purpose: 

Antibacterial

Warnings

For external use on hands only.

Directions
  • Spread product on hands thoroughly and allow to dry, do not wipe off
  • For children under 6, use only under adult supervision
  • Not recommended for use with infants
Other Information

Do not store above 105F (40.6C)

May discolor some fabrics

Harmful to plastics and wood finished

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, Yellow 5 (CI19140)

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

Decreases bacteria on skin that could cause diseases

Recommended for repeated use

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: 

Antibacterial

Warnings

For external use on hands only.

Directions
  • Spread product on hands thoroughly and allow to dry, do not wipe off
  • For children under 6, use only under adult supervision
  • Not recommended for use with infants
Other Information (Other information)

Do not store above 105F (40.6C)

May discolor some fabrics

Harmful to plastics and wood finished

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, Yellow 5 (CI19140)

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

All Sections (JSON)