ALCOHOL SANITIZING WIPES- alcohol cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Guangzhou Baihua Co., Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic, Alcohol Sanitizing Wipes Alcohol Sanitizing Wipes to help reduce bacteria on skin. 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.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ALCOHOL SANITIZING WIPES- ALCOHOL CLOTH
GUANGZHOU BAIHUA 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._
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PURPOSE
Antiseptic, Alcohol Sanitizing Wipes
ACTIVE INGREDIENT(S)
Alcohol 75% v/v. Purpose: Antiseptic
This is a sanitizing wipe 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 sanitizing wipe 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) (75%,
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.
USE
Alcohol Sanitizing Wipes to help reduce bacteria on skin. 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 med