Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ca45395a-74e2-4fa3-b3ab-a63d6a14f254
Route
TOPICAL
Published
Effective Date 2020-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 ug)
Inactive Ingredients
Water Glycerin Guaraprolose (1300 Mpa.s At 1%) Aloe Vera Leaf Citric Acid Monohydrate Calendula Officinalis Flower Matricaria Chamomilla Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-24

Description

Ethyl Alcohol 62% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62% v/v

Uses
  • Hand sanitzer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Section 50566-9

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

Warnings
  • For external use only
  • Flammable. Keep away from heat or flame
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 at temperature below 110°F
Active Ingredients

Ethyl Alcohol 62% v/v

Inactive Ingredients

*Water, Glycerin, Hydroxypropyl Guar, Citric Acid, Calendula Officinalis Flower Extract, Chomomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice.

When Using This Product

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

Keep Out of Reach of Children.

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

Principal Display Panel – 30 Ml Bottle Label

Bathletix ®

HAND

SANITIZER

ANTI-BACTERIAL GEL

WITH ALOE VERA

KILLS 99.9%

OF GERMS

1 fl.oz./30ml


Structured Label Content

Uses
  • Hand sanitzer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Section 50566-9 (50566-9)

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

Purpose

Antiseptic

Warnings
  • For external use only
  • Flammable. Keep away from heat or flame
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 at temperature below 110°F
Active Ingredients

Ethyl Alcohol 62% v/v

Inactive Ingredients

*Water, Glycerin, Hydroxypropyl Guar, Citric Acid, Calendula Officinalis Flower Extract, Chomomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice.

When Using This Product (When using this product)

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

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.

Principal Display Panel – 30 Ml Bottle Label (Principal Display Panel – 30 mL Bottle Label)

Bathletix ®

HAND

SANITIZER

ANTI-BACTERIAL GEL

WITH ALOE VERA

KILLS 99.9%

OF GERMS

1 fl.oz./30ml


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)