ALCOHOL- 73938-2020 liquid

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Louisville Distilling Company, LLC

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

OTC DRUG

Ábendingar:

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

Leyfisstaða:

OTC monograph not final

Vara einkenni

ALCOHOL- 73938-2020 LIQUID
LOUISVILLE DISTILLING COMPANY, 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._
----------
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.
• 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.
For external use only. Flammable. Keep away from heat or flame
• 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.
• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients glycerin, hydrogen peroxide, purified water USP
ALCOHOL
Louisville Distilling Company, LLC
73938-2020 liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:739 38 -20 20
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
8 0 mL in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V)
0 .125 mL in 10 0 mL
GLYCERIN (UNII: PDC6 A3C0 OX)
1.45 mL in 10 0 mL
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE MARKETING END DATE
1
NDC:739 38 -20 20 -1 56 78 0 mL in 1 DRUM; Type 0 : No t a Co mbinatio
n Pro duct
0 3/24/20 20
2
NDC:739 38 -20 20 -2 20 8 19 0 mL in 1 DRUM; Type 0 : No t a Co
mbinatio n Pro duct
0 3/24/20 20
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa