Ameriderm

Ameriderm
SPL v1
SPL
SPL Set ID 440b711a-de12-2d28-e063-6394a90ae42a
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
Butyrospermum Parkii (shea) Butter Sodium Benzoate Cocamide Mea Methylchloroisothiazolinone D&c Red No. 33 Sodium C14-16 Olefin Sulfonate Aloe Vera Leaf Water Cocamidopropyl Betaine Citric Acid Edetate Disodium Sodium Laureth Sulfate Sodium Chloride Methylisothiazolinone D&c Yellow No. 10 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, Triethanolamine Lauryl Sulfate,

Cocamidopropyl Betaine (CAPD), Cocamide MEA,

Polyquaternium 7, Sodium Chloride, Glyceryl Distearate,

Sodium Benzoate, PEG-7 Glyceryl

Cocoate, Fragrance, Sodium C14-15 Olefin Sulfonate,

Methylchloroisothiazolinone and

Methylisothiazolinone, Aloe Barbadensis Gel,

Butyrospermum Parkii (Shea Butter), Citric Acid,

D&C RED # 33, D&C YELLOW # 10

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, Triethanolamine Lauryl Sulfate,

Cocamidopropyl Betaine (CAPD), Cocamide MEA,

Polyquaternium 7, Sodium Chloride, Glyceryl Distearate,

Sodium Benzoate, PEG-7 Glyceryl

Cocoate, Fragrance, Sodium C14-15 Olefin Sulfonate,

Methylchloroisothiazolinone and

Methylisothiazolinone, Aloe Barbadensis Gel,

Butyrospermum Parkii (Shea Butter), Citric Acid,

D&C RED # 33, D&C YELLOW # 10

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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