SPL v1
SPL
SPL Set ID 0acc9265-0159-69b1-e063-6294a90a1f1b
Route
TOPICAL
Published
Effective Date 2023-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Glycerin Trolamine Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) .alpha.-tocopherol Acetate, D- Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-27

Description

Drug Facts

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Drug Facts

Uses
  • Hand sanitizer to help decrease bacteria on the skin.
  • When water, soap & towel are not available.
  • Recommended for repeated use.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.Children must be supervised in use of this product.

Section 60561-8
  • Store in original container closed.
  • Store at 20°C to 25°C (68°F to 77°F).
  • May discolor fabrics.
Warning
  • For external use only.
  • Flammable.Keep away from fire or flame.
  • Do not apply around eyes.Do not use in ears & mouth.
  • When using this product, avoid contact with eyes. In case of contact flush eyes with water.
  • Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.
Packaging

NDC:70675-001-01

NDC:70675-001-02

NDC:70675-001-03

NDC:70675-001-04

NDC:70675-001-05

NDC:70675-001-06

NDC:70675-001-07

NDC:70675-001-08

NDC:70675-001-09

NDC:70675-001-10

Directions
  • Squirt as needed into your palms and thoroughly spread on both hands.
  • Rub into skin until dry.
Active Ingredient

Ethyl Alcohol 62.0%

Inactive Ingredients

Water, Trolamine,Glycerin, carbormer,Tocopherol Acetate, Aloe Vera.


Structured Label Content

Uses
  • Hand sanitizer to help decrease bacteria on the skin.
  • When water, soap & towel are not available.
  • Recommended for repeated use.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.Children must be supervised in use of this product.

Section 60561-8 (60561-8)
  • Store in original container closed.
  • Store at 20°C to 25°C (68°F to 77°F).
  • May discolor fabrics.
Purpose

Antimicrobial

Warning
  • For external use only.
  • Flammable.Keep away from fire or flame.
  • Do not apply around eyes.Do not use in ears & mouth.
  • When using this product, avoid contact with eyes. In case of contact flush eyes with water.
  • Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.
Packaging

NDC:70675-001-01

NDC:70675-001-02

NDC:70675-001-03

NDC:70675-001-04

NDC:70675-001-05

NDC:70675-001-06

NDC:70675-001-07

NDC:70675-001-08

NDC:70675-001-09

NDC:70675-001-10

Directions
  • Squirt as needed into your palms and thoroughly spread on both hands.
  • Rub into skin until dry.
Active Ingredient (Active ingredient)

Ethyl Alcohol 62.0%

Inactive Ingredients (Inactive ingredients)

Water, Trolamine,Glycerin, carbormer,Tocopherol Acetate, Aloe Vera.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)