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
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
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
When using this product 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 or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.
Other information
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients
glycerin, hydrogen peroxide, purified water USP
Package Label - Principal Display Panel
DR LUCID 70% ETHANOL HAND SANITIZER GEL
70% ethanol hand sanitizer gel
Product Information
Product Type
HUMAN OTC DRUG
Item Code (Source)
NDC:78346-006
Route of Administration
TOPICAL
DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
ALCOHOL (ALCOHOL)
ALCOHOL
70 mL in 100 mL
Inactive Ingredients
Ingredient Name
Strength
GLYCERIN
1.45 mL in 100 mL
HYDROGEN PEROXIDE
0.125 mL in 100 mL
WATER
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
Packaging
#
Item Code
Package Description
1
NDC:78346-006-05
100 mL in 1 BOTTLE
2
NDC:78346-006-03
296 mL in 1 BOTTLE
3
NDC:78346-006-01
3785 mL in 1 BOTTLE
4
NDC:78346-006-02
15142 mL in 1 CASE
5
NDC:78346-006-06
6000 mL in 1 CASE
6
NDC:78346-006-04
5915 mL in 1 CASE
7
NDC:78346-006-08
5920 mL in 1 CASE
8
NDC:78346-006-07
296 mL in 1 BOTTLE, PUMP
9
NDC:78346-006-09
600 mL in 1 CASE
10
NDC:78346-006-10
2400 mL in 1 CASE
11
NDC:78346-006-11
1774 mL in 1 CASE
12
NDC:78346-006-12
7098 mL in 1 CASE
13
NDC:78346-006-13
1774 mL in 1 CASE
14
NDC:78346-006-14
7098 mL in 1 CASE
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
OTC monograph not final
part333A
09/11/2020
DR LUCID 70% ETHANOL HAND SANITIZER
70% ethanol hand sanitizer liquid
