Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ea5d0478-dc73-4c01-bfdd-94c858bb1a26
Route
TOPICAL
Published
Effective Date 2020-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Propylene Glycol Aloe Vera Leaf Carbomer 934 Glycerin .alpha.-tocopherol Acetate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-29

Description

Active ingredient -   Ethyl Alcohol 75% V/V    


Medication Information

Warnings and Precautions

For external use only.

Flammable. Keep away from fire or flame.

Avoid contact with eyes. In case of contact, rinse with water immediately.

If  irritation develops, discontinue use and consult a doctor.

Indications and Usage

USES:  

  • Help decrease bacteria on the hands
  • Recommended for repeated use
Dosage and Administration

Directions:

Dispense a small amount on palms, rub lightly until dry. Do not rinse.

Other information: 

Store under 105℉.

Description

Active ingredient -   Ethyl Alcohol 75% V/V    

Section 50565-1

If swallowed, get medical help or contact a poison control center right away.

Section 51727-6

Water, Glycerin, Carbomer, Triethanolamine, Propylene Glycol, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract

Section 51945-4

Section 55105-1

Purpose - Antiseptic

Section 55106-9

Active ingredient -  Ethyl Alcohol 75% V/V    


Structured Label Content

Indications and Usage (34067-9)

USES:  

  • Help decrease bacteria on the hands
  • Recommended for repeated use
Dosage and Administration (34068-7)

Directions:

Dispense a small amount on palms, rub lightly until dry. Do not rinse.

Other information: 

Store under 105℉.

Warnings and Precautions (34071-1)

For external use only.

Flammable. Keep away from fire or flame.

Avoid contact with eyes. In case of contact, rinse with water immediately.

If  irritation develops, discontinue use and consult a doctor.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Water, Glycerin, Carbomer, Triethanolamine, Propylene Glycol, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose - Antiseptic

Section 55106-9 (55106-9)

Active ingredient -  Ethyl Alcohol 75% V/V    


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)