ARROPURE 70- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ARROPOL Chemicals, Inc.

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

ARROPURE 70- ALCOHOL GEL
ARROPOL CHEMICALS, 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._
----------
ARROPURE 70
ALCOHOL ANTISEPTIC 70%
ACTIVE INGREDIENT[S]
Alcohol 70% 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 15-30°C (59-86°F)
Avoid freezing and excessive heat above 40°C (104°F)
INACTIVE INGREDIENTS
carbomer, fragrance, glycerin, trolamine, water
PACKAGE LABEL
Label for all packages
18,927 mL NDC: 77040-268-05
208,198 mL NDC: 77040-268-55
1,040,988 mL NDC: 77040-268-00
3,785 mL NDC: 77040-268-01
1,000 mL NDC: 77040-268-11
500 mL NDC: 77040-268-16
237 mL NDC: 77040-268-08
ARROPURE 70
alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:77040-268
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K99