QUALITY METALCRAFT EXPERI-METAL ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION- alcohol gel

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Tilgængelig fra:

Sunless, Inc

Indgivelsesvej:

TOPICAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

Antiseptic Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Autorisation status:

OTC monograph not final

Produktets egenskaber

QUALITY METALCRAFT EXPERI-METAL ALCOHOL ANTISEPTIC 80% TOPICAL
SOLUTION HAND SANITIZER NON-STERILE SOLUTION- ALCOHOL GEL
SUNLESS, INC
_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._
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QUALITY METALCRAFT EXPERI-METAL ALCOHOL ANTISEPTIC 80% TOPICAL
SOLUTION HAND SANITIZER NON-
STERILE SOLUTION
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:
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.
ACTIVE INGREDIENT(S)
Alcohol 80% v/v. Purpose: Antiseptic
PURPOS E
Antiseptic
US E
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 Cente