BENEMAX- isopropyl alcohol 70% liquid 
Nugale Pharmaceutical Inc

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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Drug Facts

Active ingredient

Isopropyl alcohol 70%, USP

Purpose

Antimicrobial

Uses

as a hand sanitizer when there is no water, to reduce bacteria on the skin which can cause illness. Recommended for repeated use.

Warnings

Flammable, keep away from fire or flame

For external use only

When using this product

  • do not use in or near the eyes
  • in case of contact, rinse eyes thoroughly with water

Stop use and cantact your doctor

if a rash on irritation appear and remain at the site of contact

Keep out of reach of children.

If swallowed, get medical help right away or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredient

aloe juice (aloe barbadensis), carbomer 940NF, di-alpha-tocopheryl acetate, triethanolamine, glycerin

Product Labels

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BENEMAX 
isopropyl alcohol 70% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73700-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73700-001-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/19/2020
2NDC:73700-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2020
3NDC:73700-001-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2020
4NDC:73700-001-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/19/2020
Labeler - Nugale Pharmaceutical Inc (202595872)
Establishment
NameAddressID/FEIBusiness Operations
Nugale Pharmaceutical Inc202595872manufacture(73700-001)

Revised: 11/2021
Document Id: d1f15a7c-be04-03e4-e053-2995a90a6309
Set id: 9d630406-b216-4dbe-ab4e-29c5a07e6b54
Version: 4
Effective Time: 20211129
 
Nugale Pharmaceutical Inc