HAND SANITIZER- isopropyl alcohol gel 
Alpha Aromatics

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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Hand Sanitizer Gel (70% IPA)

The hand sanitizer is manufactured in accordance with the recommendations in 21 CFR Part 333 for alcohol based topical antimicrobial OTC products for human use.

Isopropyl Alcohol 70% (v/v).
Sorbitol 0.6% (v/v).
Gylcerin 0.6% (v/v).
PEG-27 copolymer 0.375% (v/v)
Triethanol 0.7% (v/v)
Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place a dime sized amount in hand. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

purified water USP, PEG-27 copolymer, sorbitol, glycerin, triethanolamine

Package Label - Principal Display Panel

203000 mL NDC: 75009-170-01

203000 ml label

868300 mL NDC: 75009-170-02

868300 ml label

18920 ml NDC: 75009-170-03

18920 ml label

3780 ml NDC: 75009-170-04

3780 ml label

946 ml NDC: 75009-170-05

946 ml label

HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75009-170
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
GLYCERIN (UNII: PDC6A3C0OX) 0.6 mL  in 100 mL
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J) 0.375 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
SORBITOL SOLUTION (UNII: 8KW3E207O2) 0.6 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.7 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75009-170-01203000 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
2NDC:75009-170-02868300 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
3NDC:75009-170-0318920 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
4NDC:75009-170-043780 mL in 1 JUG; Type 0: Not a Combination Product03/30/2020
5NDC:75009-170-05946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/202003/31/2021
Labeler - Alpha Aromatics (041723545)
Establishment
NameAddressID/FEIBusiness Operations
Alpha Aromatics041723545manufacture(75009-170)

Revised: 11/2022
 
Alpha Aromatics