FIRST AID ANTISEPTIC- isopropyl alcohol liquid 
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.

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70% IPA Antiseptic

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

Active Ingredient(s)

Isopropyl Alcohol 70% 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: 79363-710-16

ProtextRxx 70% IPA 16oz

LifesGuard 70% IPA 16oz

Globesafe 70% IPA 16oz

Eclipse 70% IPA  16oz

946 ml NDC: 79363-710-32

ProtextRxx 70% IPA 32oz

Globesafe 70% IPA 32oz

LifesGuard 70% IPA 32oz

Eclipse 70% IPA  32oz

237ml NDC: 79363-710-08

ProtextRxx 70% IPA 8oz

3785ml NDC: 79363-710-28

ProtectRxx 70% IPA 1 Gal

Eclipse 70% IPA 1 Gal

FIRST AID ANTISEPTIC 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79363-710
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
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79363-710-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2020
2NDC:79363-710-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2020
3NDC:79363-710-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2020
4NDC:79363-710-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/17/2020
Labeler - REALCHEM MANUFACTURING (120491681)
Establishment
NameAddressID/FEIBusiness Operations
REALCHEM MANUFACTURING117584702manufacture(79363-710) , pack(79363-710) , repack(79363-710)
Establishment
NameAddressID/FEIBusiness Operations
RealChem Manufacturing Inc117742005manufacture(79363-710) , pack(79363-710) , repack(79363-710)
Establishment
NameAddressID/FEIBusiness Operations
REALCHEM MANUFACTURING117828480manufacture(79363-710) , pack(79363-710) , repack(79363-710)
Establishment
NameAddressID/FEIBusiness Operations
REALCHEM MANUFACTURING120491681manufacture(79363-710) , pack(79363-710) , repack(79363-710)

Revised: 2/2021
Document Id: ba8a9238-17f2-548a-e053-2a95a90ac54b
Set id: ad19c43e-9f28-58c5-e053-2a95a90a0bd8
Version: 8
Effective Time: 20210204
 
REALCHEM MANUFACTURING