a0b337ce-871d-6376-e053-2a95a90a9eaf

SPL v1
SPL
SPL Set ID a0b337ce-871d-6376-e053-2a95a90a9eaf
Route
topical
Published
Effective Date 2020-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
glycerin trolamine water carbomer copolymer type b (allyl pentaerythritol crosslinked)

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-04-03

Purpose

Antimicrobial

Description

Ethyl alcohol 75% v/v


Medication Information

Warnings

Flammable. Keep away from fire or flame. For external use only

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Purpose

Antimicrobial

Directions
  • Wet hands thoroughly and rub together until dry
  • No towels needed
Other Information
  • Store below 110°F (43°C)
Inactive Ingredients

Water (Aqua), Isopropyl Alcohol, Glycerin, Carbomer, Triethanolamine

Description

Ethyl alcohol 75% v/v

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 appears and lasts

Section 50570-1

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Section 51945-4

16.9 FL OZ (500ml)

Active Ingredient

Ethyl alcohol 75% v/v


Structured Label Content

Warnings

Flammable. Keep away from fire or flame. For external use only

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Purpose

Antimicrobial

Directions
  • Wet hands thoroughly and rub together until dry
  • No towels needed
Other Information (Other information)
  • Store below 110°F (43°C)
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Isopropyl Alcohol, Glycerin, Carbomer, Triethanolamine

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 appears and lasts

Section 50570-1 (50570-1)

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Section 51945-4 (51945-4)

16.9 FL OZ (500ml)

Active Ingredient (Active ingredient)

Ethyl alcohol 75% v/v


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)