BACIBAN 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:

Bonaventura Industries Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic, Hand Sanitizer Hand sanitizer to help reduce bacteria on the skin - 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

BACIBAN HAND SANITIZER- ALCOHOL LIQUID
BONAVENTURA INDUSTRIES INC
_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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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. 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.
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)
Active ingredient
Ethyl Alcohol 80% ...... Antiseptic, Hand Sanitize
PURPOS E
Antiseptic, Hand Sanitizer
US E
Hand sanitizer to help reduce bacteria on the skin
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 Contr