ANTIBACTERIALSPRAY- alcohol spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dongyang Medical & Hygienic Articles Co., Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

ANTIBACTERIAL , Hand sterilization. Efficacy: Efficient to kill Staphylococcus aureus, Coliform bacteria, Pseudomonas aeruginosa and Candida albicans etc. Follow the standard method to use soap to wash hands, rinse with running water, dry with sterile towels, then direct spray this product on hands and forearms until moist, wait for 3 minutes, rub hand until dry. - 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.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ANTIBACTERIALSPRAY- ALCOHOL SPRAY
DONGYANG MEDICAL & HYGIENIC ARTICLES CO., LTD.
_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._
----------
53031-023 500ML ANTIBACTERIAL SPRAY
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 75% v/v. Purpose: ANTIBACTERIAL
PURPOS E
ANTIBACTERIAL , Hand sterilization.
EFFICACY:
Efficient to kill Staphylococcus aureus, Coliform bacteria,
Pseudomonas aeruginosa and Candida
albicans etc.
US E
Follow the standard method to use soap to wash hands, rinse with
running water, dry with sterile towels,
then direct spray this product on hands and forearms until moist, wait
for 3 minutes, rub hand until dry.
WARNINGS
1.EXTREMELY FLAMMABLE.
pressurized container; protect from sunlight and don't expose to
temperatures exceeding 50 . Don't
pierce or burn,even after use. Don't spray on a naked flame or any
incandescent material. Keep it away
from the reach of children. Don't spray towards eyes.
2. External application should not be taken orally and kept