ISOPROPYL ALCOHOL 50% solution

Isopropyl Alcohol 50% by

Drug Labeling and Warnings

Isopropyl Alcohol 50% by is a Otc medication manufactured, distributed, or labeled by Hydrox Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Isopropyl Alcohol 50%

PURPOSE

Purpose:

First Aid Antiseptic

INDICATIONS & USAGE

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

WARNINGS

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

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

DOSAGE & ADMINISTRATION

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

WARNINGS AND PRECAUTIONS

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

Inactive Ingredient purified water

Principal Display Panel

Hydrox

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

INGREDIENTS AND APPEARANCE

ISOPROPYL ALCOHOL 50% 
isopropyl alcohol 50% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10565-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	50 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10565-003-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/11/2019
2	NDC: 10565-003-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/11/2019
3	NDC: 10565-003-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/11/2019
4	NDC: 10565-003-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/11/2019
5	NDC: 10565-003-99	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/11/2019

Labeler - Hydrox Laboratories (025164302)

Registrant - Hydrox Laboratories (025164302)

Establishment
Name	Address	ID/FEI	Business Operations
Hydrox Laboratories		025164302	manufacture(10565-003) , label(10565-003) , pack(10565-003)