BACIBAN- gel sanitizer gel

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 hands - 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 serious condition.

Authorization status:

OTC monograph not final

Summary of Product characteristics

BACIBAN- GEL SANITIZER GEL
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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BACIBAN GEL
ACTIVE INGREDIENT
Active ingredient
Ethyl Alcohol 80%
PURPOS E
Antiseptic, Hand Sanitizer
US ES
Hand sanitizer to help reduce bacteria on the hands
WARNINGS
For external use only-hands.
Flammable. Keep away from heat and flame. Do not use in
children less than 2 months of age on open skin wounds
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, flush thoroughly with water.
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
• Avoid freezing and excessive heat above 40C (104F)
• may discolor some fabrics • harmful to wood finishes and
plastics
INACTIVE INGREDIENTS
Glycerin, Hydrogen Peroxide, Guaraprolose, Citric Acid, Purified Water
USP
Stop use and ask a doctor if irritation or rash occurs. These may be
signs of serious condition.
Keep out of reach of children. If swallowed, get medical help of
contact a Poison Control Center
immediately.
BACIBAN
gel sanitizer gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:77330 -0 0 3(NDC:756 8 2-435)
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)
ALCOHOL
8 0 mL in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
1.45 mL in 10 0 mL
GUARAPRO LO SE ( 3 50 0 MPA.S AT 1%) (UNII: 3A1I7376 TC)
HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V)
0 .125 mL in 10 0 mL
B