HAND SANITIZER- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Industrias San-Ber, S.A. de C.V.

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

HAND SANITIZER- ALCOHOL GEL
INDUSTRIAS SAN-BER, S.A. DE C.V.
_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._
----------
ACTIVE INGREDIENT(S)
Alcohol 75% 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
Glycerin, polyacrylic acid (Carbomer), triethanolamine (Trolamine),
Water(aqua).
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
60 mL NDC :78755-001-01
PACKAGE LABEL- PRINCIPAL DISPLAY PANEL
120 mL NDC: 78755-001-02
PACKAGE LABEL- PRINCIPAL DISPLAY PANEL
250 mL NDC: 78755-001-03
PACKAGE LABEL- DISPLAY PANEL
500 mL NDC: 78755-001-04
PACKAGE LABEL- PRINCIPAL DISPLAY PANEL
1000 mL NDC: 78755-001-05
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL
3780 mL NDC: 78755-001-06
HAND SANITIZER
alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:78755-001
ROUT