FRESHANDS INSTANT HAND SANITIZER GEL- 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

FRESHANDS INSTANT HAND SANITIZER GEL- 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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70% ALCOHOL GEL SANITIZER (ACRYLATE & HPMC) AMP NEUTRALIZER
This hand sanitizer is an over the counter drug product manufactured
with active and
inactive ingredients provided below:
Active Ingredient: Ethyl Alcohol 70% v/v
Inactive Ingredients: water, acrylate copolymer, glycerin,
hydroxypropyl methylcellulose,
aloe barbadensis, tocopheryl acetate, aminomethyl propanol, fragrance
Manufacturing of this hand sanitizer is consistent with 21 CFR Part
310.
ACTIVE INGREDIENT(S)
Alcohol 70% v/v. 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 (104F)
INACTIVE INGREDIENTS
water, acrylate copolymer, glycerin, hydroxypropyl methylcellulose,
aloe barbadensis,
tocophery