United States - English - NLM (National Library of Medicine)
QUALITY METALCRAFT EXPERI-METAL ALCOHOL ANTISEPTIC 80% TOPICAL
SOLUTION HAND SANITIZER NON-STERILE SOLUTION- alcohol gel
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they
comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Quality Metalcraft Experi-Metal Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-
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
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:
a. 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.
b. Glycerol (1.45% v/v).
c. Hydrogen peroxide (0.125% v/v).
d. 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.
Alcohol 80% v/v. Purpose: Antiseptic
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water
are not available.
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
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.
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
glycerin, hydrogen peroxide, purified water USP
Package Label - Principal Display Panel
Quality Metalcraft Experimetal Inc.
Alcohol Antiseptic 80% Topical Solution
Hand Sanitizer Non-Sterile Solution
2fl. oz. / 59 mL
QUALITY METALCRAFT EXPERI-METAL ALCOHOL ANTISEPTIC 80%
TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION
Product T ype
HUMAN OTC DRUG
Ite m Code (Source )
NDC:72553-0 0 8
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)
8 0 mL in 10 0 mL
Stre ng th
GLYCERIN (UNII: PDC6 A3C0 OX)
HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V)
WATER (UNII: 0 59 QF0 KO0 R)
Marketing Start Date
Marketing End Date
NDC:72553-0 0 8 -0 1
59 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
12/10 /20 20
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
OTC mo no graph no t final
12/10 /20 20
Sunless, Inc (002603202)
Ad d re s s
Busine ss Ope rations
0 0 26 0 320 2
ma nufa c ture (72553-0 0 8 )