Dodys

Dodys
SPL v2
SPL
SPL Set ID 6581f9e8-f32d-448e-bf18-31ee1ae50ef7
Route
TOPICAL
Published
Effective Date 2020-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Glycerin Polysorbate 20 .alpha.-tocopherol Acetate Peg-12 Dimethicone Methylisothiazolinone Iodopropynyl Butylcarbamate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-22

Description

Benzalkonium chloride 0.13%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium chloride 0.13%

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only.

Flammable, keep away from fire or flame.

Directions

Wet hands thoroughly with product and allow to dry without wiping

Do Not Use 

in the eyes

Active Ingredient

Benzalkonium chloride 0.13%

Other Information

Store in a cool place

Package Labeling:

Inactive Ingredients

Water, glycerin, polysorbate 20, tocopheryl acetate, PEG-12 dimethicone, methylisothiazolinone, iodopropynyl butylcarbamate, fragrance, citric acid

Stop Use and Ask A Doctor If
  • irritation and redness develop
  • condition persists for more than 72 hours
Keep Out of Reach of Children.

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


Structured Label Content

Use

For hand washing to decrease bacteria on the skin

Purpose

Antiseptic

Warnings

For external use only.

Flammable, keep away from fire or flame.

Directions

Wet hands thoroughly with product and allow to dry without wiping

Do Not Use  (Do not use )

in the eyes

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

Other Information (Other information)

Store in a cool place

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Water, glycerin, polysorbate 20, tocopheryl acetate, PEG-12 dimethicone, methylisothiazolinone, iodopropynyl butylcarbamate, fragrance, citric acid

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation and redness develop
  • 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 right away.


Advanced Ingredient Data


Raw Label Data

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