ABERCROMBIE AND FITCH CO. HAND SANITIZER- alcohol liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bocchi Laboratories

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

ABERCROMBIE AND FITCH CO. HAND SANITIZER- ALCOHOL LIQUID
BOCCHI LABORATORIES
_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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ABERCROMBIE & FITCH CO. HAND SANITIZER
ACTIVE INGREDIENT
Alcohol 80% v/v
PURPOS E
Antiseptic
FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME.
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.
US ES
Hand Sanitizer to help reduce bacteria that potentially can cause
disease.
For use when soap and water are not available.
DIRECTIONS
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.
OTHER INFORMATION
Store between 15°-30°C (59°-86°F).
Avoid freezing and excessive heat about 40°C (104°F)
INACTIVE INGREDIENTS Glycerin, Hydrogen Peroxide, Purified Water USP
DO NOT USE
In children less than 2 months of age
On open skin wounds
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:
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.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.1