ENVIROSOLUTIONS SANITIZING WIPES- isopropyl alcohol cloth

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
08-02-2021

Aktiv ingrediens:

ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)

Tilgjengelig fra:

Charlotte Products Ltd.

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

Antiseptic, Hand Sanitizer Personal hand sanitizing wipe to help reduce bacteria that potentially can cause disease. - 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.

Autorisasjon status:

OTC monograph not final

Preparatomtale

                                ENVIROSOLUTIONS SANITIZING WIPES- ISOPROPYL ALCOHOL CLOTH
CHARLOTTE PRODUCTS 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._
----------
ENVIROSOLUTIONS ES40 SANITIZING WIPES
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. Isopropyl Alcohol (75%, 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)
Isopropyl Alcohol 70% v/v. Purpose: Antiseptic
PURPOS E
Antiseptic, Hand Sanitizer
US E
Personal hand sanitizing wipe to help reduce bacteria that potentially
can cause disease.
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.
DIRECTIONS
• Open the plastic tab at the front of the bottle. Pull up wipe and
replace plastic cap. Always snap lid
securely shut between uses to prevent moisture loss.

                                
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