ISOPROPYL ALCOHOL 99%- isopropyl alcohol 99% liquid 
UBQ Industries, 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.

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Isopropyl Alcohol 99%

Active Ingredient(s)

Isopropyl Alcohol 99% v/v. Purpose: Antiseptic

Purpose Section

first aid antiseptic, isopropyl alcohol

Indications and usage section

first aid to help prevent the risk of infection in minor cuts, scrapes and burns

Warnings Section

For external use only. Flammable. Keep away from heat or flame

Ask a doctor before use if you have

deep puncture wounds, animal bites or serious burns

When using this product

do not get into eyes, do not apply over large areas of the body, do not use longer than one week unless directed by a doctor

Stop using this product if

condition persists or gets worse

Keep this and all drugs our of the reach of children

In case of accidentail ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately

Directions

clean effected area. apply small amount of this product on the area 1 - 3 times daily, may be covered with a sterile bandage, if bandaged, let dry first

Other information

store at room temperature. does not contain, nor is intended as a substitute for grain or ethyl alcohol. will produce serious gastric disturbances if taken internally

Inactive Ingredients

purified water

Package Label - Principal Display Panel

236 ml NDC 80668-414-05
236 ml - IPA

946.4 ml NDC 80668-414-06
946.4 ml - IPA

18927 ml NDC 80668-414-01
ipa-5g

3785 ml NDC 80668-414-02
ipa-128

1892 ml NDC 80668-414-03
ipa-64

IPA-16473.2ml NDC 80668-414-04

ISOPROPYL ALCOHOL 99% 
isopropyl alcohol 99% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80668-414
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL99 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 1 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80668-414-0118927 mL in 1 PAIL; Type 0: Not a Combination Product03/20/2020
2NDC:80668-414-023785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/20/2020
3NDC:80668-414-031892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/20/2020
4NDC:80668-414-04473.2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/20/2020
5NDC:80668-414-06946.4 mL in 1 JUG; Type 0: Not a Combination Product03/20/2020
6NDC:80668-414-05236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/20/2020
Labeler - UBQ Industries, LLC (069021187)
Establishment
NameAddressID/FEIBusiness Operations
UBQ Industries, LLC069021187repack(80668-414) , manufacture(80668-414) , relabel(80668-414)

Revised: 11/2021
Document Id: d179108c-c470-8691-e053-2a95a90ace7a
Set id: b56cfda8-459c-5691-e053-2995a90a5a31
Version: 3
Effective Time: 20211123
 
UBQ Industries, LLC