BIORELL- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Chaptec Inc

Administration route:

CUTANEOUS

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Authorization status:

OTC monograph not final

Summary of Product characteristics

BIORELL- ALCOHOL GEL
CHAPTEC 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._
----------
BIORELL
DRUG FACTS
ACTIVE INGREDIENT[S]
Alcohol 70 % v/v
PURPOS E
Antiseptic
US E[S ]
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.
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 59 - 86 °F (15 - 30 °C).
Avoid freezing and excessive heat above 104 °F (40 °C).
INACTIVE INGREDIENTS
carbomer, fragrance, glycerin, isopropyl alcohol, trolamine, water.
QUESTIONS OR COMMENTS?
1 514 498-3620
Monday to Friday, 8:30 a.m.- 4:30 p.m.
PRINCIPAL DISPLAY PANEL - 3.78 L BOTTLE LABEL
Odor of Green Apple
Biorell
Hand Sanitizer
Non-sterile
Solution
Alcohol Antiseptic 70%
Topical Solution
Net Content
3.78 L
BIORELL
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:79 738 -0 0 1
Chaptec Inc
ROUTE OF ADMINISTRATION
CUTANEOUS
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
CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)
GLYCERIN (UNII: PDC6 A3C0 OX)
ISO PRO PYL A LCO