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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. 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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ACTIVE INGREDIENT
Active ingredient
Ethyl Alcohol 70%
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. Keep out of
reach of children. If swallowed,
get medical help or contact a Poison Control Center immediately.
WHEN USING THIS PRODUCT
Keep out of eyes, ears, and mouth.
In case of contact with eyes, flush thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs.
These may be signs of a serious condition.
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
Purified water, Hydrogen Peroxide, Carbomer, and Glycerin
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 2(NDC:55549 -0 0 2)
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
70 mL in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
23.3 mL in 10 0 mL
GLYCERIN (UNII: PDC6