SPL v2
SPL
SPL Set ID ac6771a1-8740-8334-e053-2a95a90a250a
Route
TOPICAL
Published
Effective Date 2021-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Didecyldimonium (0.1 g)
Inactive Ingredients
Loureirin B Leuconostoc/radish Root Ferment Filtrate

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-03-01

Description

DIDECYLDIMONIUM BROMIDE 0.1%, Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

DIDECYLDIMONIUM BROMIDE 0.1%, Purpose: Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

DIDECYLDIMONIUM BROMIDE 0.1%, Purpose: Antiseptic

Inactive Ingredients

leuconostoc/radish root ferment, loureirin B, purified water USP

Package Label Principal Display Panel

60 ml NDC: 80018-101-01

300 ml NDC: 80018-101-02

300 ml refill NDC: 80018-101-03


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic, Hand Sanitizer

Warnings

For external use only.

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

DIDECYLDIMONIUM BROMIDE 0.1%, Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

leuconostoc/radish root ferment, loureirin B, purified water USP

Package Label Principal Display Panel (Package Label - Principal Display Panel)

60 ml NDC: 80018-101-01

300 ml NDC: 80018-101-02

300 ml refill NDC: 80018-101-03


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)