HAND SANITIZER- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Consolidated Chemicals, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic, Hand Sanitizer 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.

Authorization status:

OTC monograph not final

Summary of Product characteristics

HAND SANITIZER- ALCOHOL GEL
CONSOLIDATED CHEMICALS, LLC
_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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80% ALCOHOL GEL SANITIZER
HAND SANITIZER ALCOHOL GEL
This hand sanitizer is manufactured using the following ingredients in
the preparation of
the product (wt% in final product formulation) consistent with 21 CFR
Part 310:
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80 wt%)
in an aqueous
solution denatured according to Alcohol and Tobacco Tax and Trade
Bureau
regulations in 27 CFR part 20.
b. Glycerol USP Grade (2 wt%).
c. Hydrogen peroxide (0.14 wt%).
d. Hydroxypropyl methylcellulose USP (0.75 wt%)
e. Distilled water
The firm does not add other active or inactive ingredients.
ACTIVE INGREDIENT(S)
Alcohol 80%. Purpose: Antiseptic
PURPOSE
Antiseptic, Hand Sanitizer
USE
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
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 medical help or
contact a Poison Control
Center right away.
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 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (1