SPL v1
SPL
SPL Set ID 621624d2-6eb1-441c-b3ac-e0255d6cef7f
Route
TOPICAL
Published
Effective Date 2020-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Glycerin Propylene Glycol Water Carbomer 934 Trolamine Alpha-tocopherol Acetate Aloe Vera Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-20

Description

NA

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

NA

Use

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

Section 42229-5

NA

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 redness develops

Section 50567-7

When using this product avoid contact with face, eyes and broken skin. In case of contact, flush with plenty of water and seek medical advice

Section 51945-4

Warnings

For external use only

Flammable. Keep away from heat and flame

Directions
  • Wet hands thoroughly with product and rub into skin until dry
  • Children under 6 years of age should be supervised by an adult when using
Active Ingredient(s)

Ethyl Alcohol 70% v/v

Inactive Ingredients

Water, triethanolamine, carbomer, aloe barbadensis (aloe vera) gel, fragrance, propylene glycol, glycerin, tocopheryl acetate (Vitamin E)


Structured Label Content

Use

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

Section 42229-5 (42229-5)

NA

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 redness develops

Section 50567-7 (50567-7)

When using this product avoid contact with face, eyes and broken skin. In case of contact, flush with plenty of water and seek medical advice

Section 51945-4 (51945-4)

Purpose

Antimicrobial

Warnings

For external use only

Flammable. Keep away from heat and flame

Directions
  • Wet hands thoroughly with product and rub into skin until dry
  • Children under 6 years of age should be supervised by an adult when using
Active Ingredient(s)

Ethyl Alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

Water, triethanolamine, carbomer, aloe barbadensis (aloe vera) gel, fragrance, propylene glycol, glycerin, tocopheryl acetate (Vitamin E)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)