SPL v1
SPL
SPL Set ID ab76a1a8-e18a-6541-e053-2a95a90af264
Route
TOPICAL
Published
Effective Date 2020-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Lavender Oil Water Butylene Glycol Hyaluronate Sodium 1,2-hexanediol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-28

Description

Ethyl alcohol 70% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 70% v/v

Uses

Hand sanitizer to help reduce bacteria potentially can cause disease. For use when soap and water are not available.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Section 50566-9

​Discontinue if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Section 50567-7

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

Warnings

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

Questions

☎323-728-8555

Directions
  • Place enough product in your palm to thoroughly cover your hands.
  • 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 month of age
  • On open skin wounds
Drug Facts

Active Ingredient

Ethyl alcohol 70% v/v

Other Information
  • Store between 15-30˚C (59-86˚F)
  • Avoid freezing and excessive heat above 40˚C (104˚F)
  • May discolor certain fabrics.
Inactive Ingredients

Water, Butylene Glycol, Glycerin, Lavandula Angustifolia (Lavender) Oil, 1,2-Hexanediol, Sodium Hyaluronate


Structured Label Content

Uses

Hand sanitizer to help reduce bacteria potentially can cause disease. For use when soap and water are not available.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Section 50566-9 (50566-9)

​Discontinue if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Section 50567-7 (50567-7)

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

Purpose

Antiseptic

Warnings

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

Questions

☎323-728-8555

Directions
  • Place enough product in your palm to thoroughly cover your hands.
  • Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use (Do not use)
  • In children less than 2 month of age
  • On open skin wounds
Drug Facts

Active Ingredient

Ethyl alcohol 70% v/v

Other Information (Other information)
  • Store between 15-30˚C (59-86˚F)
  • Avoid freezing and excessive heat above 40˚C (104˚F)
  • May discolor certain fabrics.
Inactive Ingredients

Water, Butylene Glycol, Glycerin, Lavandula Angustifolia (Lavender) Oil, 1,2-Hexanediol, Sodium Hyaluronate


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)