CLAYR- alcohol spray 
CLAYR- citric acid, cinnamonoil spray 
Sunbio Corporation

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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Product 81311-025 Active Ingredients: ALCOHOL
Product 81311-015 Active Ingredients: CITRIC ACID MONOHYDRATE, CINNAMON OIL

Product NDC: 81311-025:

Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Product NDC: 81311-025:

HYDROGEN PEROXIDE, GLYCERIN, CINNAMON OIL, ANHYDROUS CITRIC ACID, WATER

Product NDC: 81311-025:

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

Product NDC: 81311-025:

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Product NDC: 81311-025:

Antiseptic

Product NDC: 81311-025:

Alcohol 80% v/v

Product NDC: 81311-025:

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

Product NDC: 81311-025:

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

Product NDC: 81311-025:

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Product NDC: 81311-025:

if irritation or rash occurs. These may be signs of a serious condition.

Product NDC: 81311-025:

Store between 15-30C (59-86F)

• Avoid freezing and excessive heat above 40C (104F)

60 mL NDC: 81311-015-60 60 mL NDC: 81311-015-60 label

300 mL NDC: 81311-015-30 300 mL NDC: 81311-015-30 label

1000 mL NDC: 81311-015-10 1000 mL NDC: 81311-015-10 label

3785 mL NDC: 81311-015-37 3785 mL NDC: 81311-015-37 label

60 mL NDC: 81311-025-60 60 mL NDC: 81311-025-60 label

300 mL NDC: 81311-025-30 300 mL NDC: 81311-025-30 label

1000 mL NDC: 81311-025-10 1000 mL NDC: 81311-025-10 label

3785 mL NDC: 81311-025-37 3785 mL NDC: 81311-025-37 label

CLAYR 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81311-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL800 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
CINNAMON OIL (UNII: E5GY4I6YCZ)  
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81311-025-6060 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2021
2NDC:81311-025-30300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2021
3NDC:81311-025-101000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2021
4NDC:81311-025-373785 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/202109/30/2021
CLAYR 
citric acid, cinnamonoil spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81311-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CINNAMON OIL (UNII: E5GY4I6YCZ) (CINNAMON OIL - UNII:E5GY4I6YCZ) CINNAMON OIL1 g  in 1000 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID5 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 940 mL  in 1000 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81311-015-6060 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2021
2NDC:81311-015-30300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2021
3NDC:81311-015-101000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2021
4NDC:81311-015-373785 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/202109/30/2021
Labeler - Sunbio Corporation (809434231)
Establishment
NameAddressID/FEIBusiness Operations
Sunbio Corporation809434231manufacture(81311-015, 81311-025)

Revised: 12/2021
Document Id: d30a0f73-4c6c-9f05-e053-2995a90a50e4
Set id: b6d727f2-29ff-3d0a-e053-2995a90a9217
Version: 2
Effective Time: 20211213
 
Sunbio Corporation