HAND SANITIZER- ethyl alcohol liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Millstone Spirits Group LLC

Administration route:

TOPICAL

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. - 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- ETHYL ALCOHOL LIQUID
MILLSTONE SPIRITS GROUP LLC
_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._
----------
HAND SANITIZER
Alcohol 80 % v/v
Antiseptic
Hand Sanitizer to help reduce bacteria that potentially can cause
disease. For use when
soap and water are not available.
For external use only. Flammable. Keep away from heat or flame
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.
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 40 C (104F)
Inactive ingredients glycerin, hydrogen peroxide, purified water USP
HAND SANITIZER
Hand Sanitizer Front Label
New Liberty Distillery Philadelphia PA
Alcohol
Glycerin
water
hydrogen perozide
8 ounces
HAND SANITIZER
ethyl alcohol liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:73887-236
ROUTE OF ADMINISTRATION
TOPICAL
Millstone Spirits Group LLC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
80 mL in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:73887-
236-02
10000 mL in 1 BOTTLE; Type 0: Not a Combination
Product
03/28/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part3