Isopropyl Alcohol by US+ Healthcare Products

Isopropyl Alcohol by

Drug Labeling and Warnings

Isopropyl Alcohol by is a Otc medication manufactured, distributed, or labeled by US+ Healthcare Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ISOPROPYL ALCOHOL- isopropyl alcohol liquid 
US+ Healthcare Products

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.

----------

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic.

Antiseptic.

USES: First aid to help prevent the risk of infection in minor cuts, scrapes, burns.

For external use only. If taken internally serious gastric disturbances will result.

Flammable. Keep away from fire or flame, heat, spark, electrical.

Ask a doctor before use for deep or puncture wounds, animal bites or serious burns.

When using this product: do not get into eyes, do not inhale, do not apply over large areas of the body, do not use longer than 1 week.

Stop use and ask a doctor if condition persists or gets worse.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Caution: Fumes can be acutely irritating to skin and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

Directions.

Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other information

Does not contain, nor is intended as a substitute for grain or ethyl alcohol.

Inactive ingredient

Purified water USP

Package Label

ISOPROPYL ALCOHOL 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78557-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 30 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78557-301-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/14/202006/01/2021
2NDC: 78557-301-021893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/14/202009/15/2020
3NDC: 78557-301-22236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/14/202009/15/2020
4NDC: 78557-301-03946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/18/202011/19/2020
5NDC: 78557-301-04473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/18/202012/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/14/202006/01/2021
Labeler - US+ Healthcare Products (117538042)
Registrant - US+ Healthcare Products (117538042)
Establishment
NameAddressID/FEIBusiness Operations
US+ Healthcare Products117538042manufacture(78557-301)

Revised: 6/2021
Document Id: c5a31a75-1b75-5988-e053-2995a90a701e
Set id: af112ab7-facc-1bcb-e053-2995a90a2a7f
Version: 7
Effective Time: 20210625