BENEMAX: Package Insert and Label Information

BENEMAX- isopropyl alcohol 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.

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

  • spray 3ยท5 pumps of hand sanitizer onto hands or enough to thoroughly cover hands.
  • children under 6 years of age must be supervised when using this product.

Other information

  • do not store above 1100 F (430 C). May discolor certain fabrics or substances

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 Type HUMAN OTC DRUG Item Code (Source) NDC:73700-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
.ALPHA.-TOCOPHEROL ACETATE, DL-
TROLAMINE
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73700-001-01 60 mL in 1 BOTTLE, SPRAY None
2 NDC:73700-001-02 60 mL in 1 BOTTLE None
3 NDC:73700-001-03 236 mL in 1 BOTTLE None
4 NDC:73700-001-04 1000 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333A 03/19/2020
Labeler — Nugale Pharmaceutical Inc (202595872)
Establishment
Name Address ID/FEI Operations
Nugale Pharmaceutical Inc 202595872 manufacture (73700-001)

Revised: 06/2020 Nugale Pharmaceutical Inc

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