HAND SANITIZER- isopropyl alcohol liquid 
RealChem Manufacturing 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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99% IPA Antiseptic

This is a first aid antiseptic manufactured according to FDA Guidance.

Active Ingredient(s)

Isopropyl Alcohol 99% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Antiseptic to decrease germs in minor cuts and scrapes and for preparation of skin prior to an injection; 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

purified water USP

Package Label - Principal Display Panel

473 ml NDC: 79363-990-16

ProtectRxx  99% IPA 16oz

237ml NDC: 79393-990-08

ProtectRxx  99% IPA 8oz

3785ml NDC: 79363-990-28

ProtectRxx  99% IPA 1 Gal

946ml NDC: 79363-990-32

ProtectRxx  99% IPA 32oz

HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79363-990
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL99 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79363-990-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/30/2020
2NDC:79363-990-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/30/2020
3NDC:79363-990-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product10/30/2020
4NDC:79363-990-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product10/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/30/2020
Labeler - RealChem Manufacturing Inc (120491681)
Establishment
NameAddressID/FEIBusiness Operations
RealChem Manufacturing Inc117584702manufacture(79363-990) , pack(79363-990) , repack(79363-990)
Establishment
NameAddressID/FEIBusiness Operations
REALCHEM MANUFACTURING117742005manufacture(79363-990) , pack(79363-990) , repack(79363-990)
Establishment
NameAddressID/FEIBusiness Operations
REALCHEM MANUFACTURING117828480manufacture(79363-990) , pack(79363-990) , repack(79363-990)
Establishment
NameAddressID/FEIBusiness Operations
RealChem Manufacturing Inc120491681pack(79363-990) , repack(79363-990) , manufacture(79363-990)

Revised: 2/2021
Document Id: ba76f6bb-822a-22c4-e053-2995a90a0975
Set id: b32458ce-bfd3-60c5-e053-2995a90ae813
Version: 4
Effective Time: 20210203
 
RealChem Manufacturing Inc