Rough And Smooth Heavy Duty Antiseptic Hand Sanitizer

Rough And Smooth Heavy Duty Antiseptic Hand Sanitizer
SPL v4
SPL
SPL Set ID ad67aa59-1fe5-0d75-e053-2995a90ac7e0
Route
TOPICAL
Published
Effective Date 2020-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Poloxalene Peg-75 Lanolin Glycerin Polyethylene Glycol, Unspecified Lauryl Glucoside Edetate Disodium Anhydrous Bronopol Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-30
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

Directions
  • Peel back the foil seal and pull the center wipe through the slot in the lid.
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Close lid after use to prevent wipes from drying out.
Do Not Use

in the eyes

Active Ingredient

Benzalkonium chloride 0.13%

Package Labeling:

Inactive Ingredients

Water, Estasol, Poloxalene, PEG-75 Lanolin, Glycerin, Aloe Barbadensis Extract, Polyethylene glycol, Lauryl Glycosides, Fragrance, Disodium EDTA, 2-bromo-2-nitropropane-1,3-diol, 1,2-benzisothiazolin-3-one.

Package Labeling:2wipes

Package Labeling:40wipes

Stop Use and Ask A Doctor If
  • irritation and redness develop.
  • If condition persists for more than 72 hours consult a doctor.
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

Directions
  • Peel back the foil seal and pull the center wipe through the slot in the lid.
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Close lid after use to prevent wipes from drying out.
Do Not Use (Do not use)

in the eyes

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Water, Estasol, Poloxalene, PEG-75 Lanolin, Glycerin, Aloe Barbadensis Extract, Polyethylene glycol, Lauryl Glycosides, Fragrance, Disodium EDTA, 2-bromo-2-nitropropane-1,3-diol, 1,2-benzisothiazolin-3-one.

Package Labeling:2wipes

Package Labeling:40wipes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation and redness develop.
  • If condition persists for more than 72 hours consult a doctor.
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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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:06.392986 · Updated: 2026-03-14T23:01:33.532889