Drug Facts

Active Ingredient

Isopropyl Alcohol 50%

Purpose:

First Aid Antiseptic

Usesfirst 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

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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

isopropylalcohol

ISOPROPYL ALCOHOL 50%
isopropyl alcohol 50% solution

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M003	06/11/2019

Labeler - Hydrox Laboratories (025164302)

Registrant - Hydrox Laboratories (025164302)

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

Isopropyl Rubbing Alcohol 50%

Drug Facts

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