HAND SANITIZER- alcohol gel 
REALCHEM MANUFACTURING

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.

----------

70% EtOH gel scented HS

This is a hand sanitizer scented gel manufactured according to FDA Guidance

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

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

Other information

Inactive ingredients

glycerin, RapidGel EZ1, purified water USP, Fragrance (Parfum)

Package Label - Principal Display Panel

1041 L NDC: 79363-702-00 Trinity 275 Gal Tote

3785 ml NDC: 79363-702-28

1 Gal Driftless Life 70% Plumeria

1 Gal Driftless Life Lemongrass

NexxChem 70% LemonGrass Gel 1 Gallon

NexxChem 70% LemonGrass Gel Gallon

LifesGuard 70% Scented Gel 1 Gal 3785 ml NDC: 79363-702-28

Trinity 1 Gallon Scented

3785 ml NDC: 79363-702-28

CHD 1 Gal 70% Scented Gel

237 ml NDC: 79363-702-08

8 oz DriftlessLife 70% Plumeria

8 oz DriftlessLife 70% LemonGrass

ProtectRxx 70% Plumeria Gel

ProtextRxx 70% Lemongrass Gel

ProtextRxx 70% LimeSeaSalt Gel

NDC 79363-702-16 473ml

NexxChem 70% LemonGrass 16oz Gallon

NexxChem 70% LimeSeaSalt 16oz

NDC 79363-702-32

32 oz Driftless Life 70% Plumeria

32 oz Driftless Life 70% LemonGrass

NexxChem 70% LemonGrass Gel 32oz

NexxChem 70% LimeSeaSalt Gel 32oz

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79363-702
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
RAPIDGEL EZ1 (UNII: 33JH4A7R2K) 1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79363-702-001041000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product08/12/2020
2NDC:79363-702-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/12/2020
3NDC:79363-702-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/12/2020
4NDC:79363-702-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/12/2020
5NDC:79363-702-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product08/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/12/2020
Labeler - REALCHEM MANUFACTURING (120491681)
Establishment
NameAddressID/FEIBusiness Operations
REALCHEM MANUFACTURING117584702manufacture(79363-702) , pack(79363-702) , repack(79363-702)
Establishment
NameAddressID/FEIBusiness Operations
REALCHEM MANUFACTURING117742005manufacture(79363-702) , pack(79363-702) , repack(79363-702)
Establishment
NameAddressID/FEIBusiness Operations
REALCHEM MANUFACTURING120491681manufacture(79363-702) , pack(79363-702) , repack(79363-702)
Establishment
NameAddressID/FEIBusiness Operations
REALCHEM MANUFACTURING117828480manufacture(79363-702) , pack(79363-702) , repack(79363-702)

Revised: 1/2021
Document Id: b9c21c8c-1560-76a4-e053-2995a90a3d7f
Set id: aca29af8-ad3c-c760-e053-2995a90ae26a
Version: 8
Effective Time: 20210125
 
REALCHEM MANUFACTURING