Amerisilk

Amerisilk
SPL v1
SPL
SPL Set ID 43f9775c-0448-243e-e063-6294a90a9e22
Route
TOPICAL
Published
Effective Date 2025-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Cocamide Mea Sodium Benzoate Methylchloroisothiazolinone D&c Red No. 33 Sodium C14-16 Olefin Sulfonate Citric Acid Aloe Vera Leaf Water Cocamidopropyl Betaine Edetate Disodium Sodium Laureth Sulfate Sodium Chloride Methylisothiazolinone Fd&c Blue No. 1 Polyquaternium-7 Peg-7 Glyceryl Cocoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-19

Description

Benzalkonium Chloride...0.10% w/w

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride...0.10% w/w

Uses

• for hand washing to decrease bacteria on the skin • recommended for repeated use

• for body wash to help reduce bacteria that can potentially cause disease

Section 51945-4

Warnings

​ For external use only

Directions

• Apply to hands and wet as needed, vigorously

work into a lather and rinse thoroughly

Active Ingredient

Benzalkonium Chloride...0.10% w/w

Other Information

Store in a cool dry place below 104 F°

Inactive Ingredients:

Water, Sodium Laureth

Sulfate, CAPB, Polyquaternium 7, Sodium

Chloride, Cocamide MEA, Sodium C14-15 Olefin

Sulfonate, Sodium Benzoate, PEG-7 Glyceryl

Cocoate, Fragrance, Methylchloroisothiazolinone

and Methylisothiazolinone, Aloe Barbadensis Gel,

Disodium EDTA, Citric Acid, D&C RED # 33,

FD&C BLUE # 1

When Using This Product

• Avoid contact with eyes, in case of eye contact flush with water

Stop Use and Ask A Doctor

if irritation and redness develops

Keep Out of Reach of Children

If swallowed, get medical help or Poison Control Center right away


Structured Label Content

Uses

• for hand washing to decrease bacteria on the skin • recommended for repeated use

• for body wash to help reduce bacteria that can potentially cause disease

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings

​ For external use only

Directions

• Apply to hands and wet as needed, vigorously

work into a lather and rinse thoroughly

Active Ingredient (Active ingredient)

Benzalkonium Chloride...0.10% w/w

Other Information (Other information)

Store in a cool dry place below 104 F°

Inactive Ingredients:

Water, Sodium Laureth

Sulfate, CAPB, Polyquaternium 7, Sodium

Chloride, Cocamide MEA, Sodium C14-15 Olefin

Sulfonate, Sodium Benzoate, PEG-7 Glyceryl

Cocoate, Fragrance, Methylchloroisothiazolinone

and Methylisothiazolinone, Aloe Barbadensis Gel,

Disodium EDTA, Citric Acid, D&C RED # 33,

FD&C BLUE # 1

When Using This Product (When using this product)

• Avoid contact with eyes, in case of eye contact flush with water

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

if irritation and redness develops

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

If swallowed, get medical help or Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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