Isopropyl Rubbing Alcohol

Isopropyl Rubbing Alcohol

Drug Labeling and Warnings

Drug Details

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ISOPROPYL ALCOHOL 50%- isopropyl alcohol 50% solution 
Hydrox Laboratories

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 Rubbing Alcohol

Drug Facts

Active Ingredient

Isopropyl Alcohol 50%

Purpose:

First Aid Antiseptic

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

Warnings For external use only

Flammable

  • Keep away from fire or flame, heat, spark, electrical. Flash point 72°F.
  • do not use with eletocautery procedures.

Ask a doctor before use if you have deep or 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 1 week unless directed by a doctor

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.

<Directions clean the affected area. apply 1 to 3 times daily.

Other information does not contain, nor is intended as a substitue for grain or ethyl alcohol. will produce serious gastric disturbances if taken internally.

Inactive Ingredient purified water

Principal Display Panel

isopropylalcoholHydrox

Isopropyl Rubbing Alcohol

A cooling and refreshing and massaging compound

50% 

First Aid Antiseptic

TAMPER EVIDENT CAP FOR YOUR PROTECTION.  IF RING-BAND IS DETACHED FROM CAP OR MISSING, DO NOT USE.

WARNING: FLAMMABLE!

Hydrox Laboratories

Elgin, IL 60123

isopropylalcohol

ISOPROPYL ALCOHOL 50% 
isopropyl alcohol 50% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10565-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL50 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10565-003-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/2019
2NDC: 10565-003-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/2019
3NDC: 10565-003-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/2019
4NDC: 10565-003-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/2019
5NDC: 10565-003-993785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/11/2019
Labeler - Hydrox Laboratories (025164302)
Registrant - Hydrox Laboratories (025164302)
Establishment
NameAddressID/FEIBusiness Operations
Hydrox Laboratories025164302manufacture(10565-003) , label(10565-003) , pack(10565-003)

Revised: 11/2019
 
Hydrox Laboratories


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