Advanced Hand Sanitizer
- Dosage form
- LIQUID
- Labeler
- Sanare Bioscience
- Label updated
- 2020-06-10
- Retrieved
- 2026-09-07
- Active ingredients
- ALCOHOL
Label information
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Active Ingredient(s)
Alcohol 80% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
For hand washing to decrease bacteria on the skin - recommended for repeated use.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
- in children less than 2 months of age
- on open skin wounds
Label information
Keep out of eyes, ears, and mouth.
In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation occurs. These may be
signs of a serious condition. Keep out of reach of children. I
swallowed, get medical help immediately or contact a Poison
Control Center immediately
Label information
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Label information
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Wet hands thoroughly with product, and allow to
dry without wiping. For children under six, use only under
adult supervision
Other information
- Store between 15-30C. Avoid freezing and
excessive heat above 40C (104F). May discolor some fabrics.
Harmful to wood finishes and plastics
Inactive ingredients
glycerin, hydrogen peroxide, Lemon Grass Fragrance, purified water USP
Package Label - Principal Display Panel
[Image in the official label — see DailyMed source]
2 oz (59mL) NDC: 78515-001-02or
4 oz (118 mL) NDC: 78515-001-04
or
8 oz (236 mL) NDC: 78515-001-08
or
128 oz (3785 mL) NDC: 78515-001-28
DailyMed Set ID: a71000cc-f836-55f8-e053-2995a90a0c63 · Version 2
NDC: 78515-001