ISOPROPYL ALCOHOL WITH WINTERGREEN 50%- isopropyl alcohol with wintergreen 50% solution 
Hydrox Laboratories

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Isopropyl Alcohol 50% with Wintergreen

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

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

When using this product

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 ● may be covered with a sterile bandage ● if bandaged, let dry first

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

FD&C Blue No. 1, FD&C Yellow No. 5, Methyl Salicylate, PEG-75 Lanolin, Purified Water

Principal Display Panel

Hydrox

Isopropyl Alcohol 50% with Wintergreen

A cooling and refreshing and massaging compound

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 WITH WINTERGREEN 50% 
isopropyl alcohol with wintergreen 50% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10565-007
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10565-007-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/19/2019
2NDC:10565-007-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/19/2019
3NDC:10565-007-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/19/2019
4NDC:10565-007-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/19/2019
5NDC:10565-007-993785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00306/19/2019
Labeler - Hydrox Laboratories (025164302)
Registrant - Hydrox Laboratories (025164302)
Establishment
NameAddressID/FEIBusiness Operations
Hydrox Laboratories025164302manufacture(10565-007) , label(10565-007) , pack(10565-007)

Revised: 10/2023
Document Id: 08a50ea6-e201-b217-e063-6394a90a95c1
Set id: 3a15a900-2b48-487f-b252-a1a1e0d0abfc
Version: 9
Effective Time: 20231026
 
Hydrox Laboratories