COROCCLEAN HAND SANITIZER- isopropyl alcohol liquid 
COROCLEAN HAND SANITIZER- isopropyl alcohol liquid 
Rhydburg Pharmaceuticals Limited

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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The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation)

  1. Isopropyl Alcohol (70%, v/v)
  2. Glycerol (0.5% v/v).
  3. Propylene Glycol (1% v/v).
  4. Carbomer 940 (0.20% v/v)
  5. SodiumHydroxide (0.015% v/v)
  6. Lemongrass Oil ( INHS) (0.10% v/v)
  7. Purified water q. s. to 1 ml

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. 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, Propylene Glycol, Carbomer 940,Sodium Hydroxide,Lemongrass Oil,purified water USP

Package Label - Principal Display Panel

100mL label200ml Label

COROCCLEAN HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78925-001
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) 0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mL  in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78925-001-10100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
2NDC:78925-001-20200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
COROCLEAN HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78925-002
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) 0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mL  in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78925-002-10100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
2NDC:78925-002-20200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Rhydburg Pharmaceuticals Limited (650552128)
Establishment
NameAddressID/FEIBusiness Operations
Rhydburg Pharmaceuticals Limited650552128manufacture(78925-001, 78925-002)

Revised: 1/2021
Document Id: b863d180-de99-6689-e053-2995a90abd03
Set id: a8f6edd2-5ac4-db20-e053-2a95a90aa838
Version: 3
Effective Time: 20210108
 
Rhydburg Pharmaceuticals Limited