ISOPROPYL ALCOHOL liquid

Isopropyl Alcohol by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Isopropyl alcohol 91%

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.

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 substitute for grain or ethyl alcohol
• will produce serious gastric disturbances if taken internally

Inactive ingredient

purified water

PRINCIPAL DISPLAY PANEL

Hydrox

TRADEMARK
SINCE 1913

Warning
Flammable

ISOPROPYL ALCOHOL

91%

TAMPER EVIDENT CAP FOR YOUR PROTECTION.

IF RING-BAND IS DETACHED FROM CAP OR MISSING DO NOT USE.

Hydrox LABORATORIES

INGREDIENTS AND APPEARANCE

ISOPROPYL ALCOHOL 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10565-071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302)	Isopropyl Alcohol	91 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: 10565-071-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/05/2019
2	NDC: 10565-071-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/05/2019
3	NDC: 10565-071-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2017
4	NDC: 10565-071-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2017
5	NDC: 10565-071-99	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	05/19/2017

Labeler - Hydrox Laboratories (025164302)

Registrant - Hydrox Laboratories (025164302)

Establishment
Name	Address	ID/FEI	Business Operations
Hydrox Laboratories		025164302	MANUFACTURE(10565-071) , label(10565-071) , pack(10565-071)