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

CLAYR by

Drug Labeling and Warnings

CLAYR by is a Otc medication manufactured, distributed, or labeled by Sunbio Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

300 mL NDC: 81311-015-30

1000 mL NDC: 81311-015-10

3785 mL NDC: 81311-015-37

60 mL NDC: 81311-025-60

300 mL NDC: 81311-025-30

1000 mL NDC: 81311-025-10

3785 mL NDC: 81311-025-37

CLAYR 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81311-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	800 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
CINNAMON OIL (UNII: E5GY4I6YCZ)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81311-025-60	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2021
2	NDC: 81311-025-30	300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2021
3	NDC: 81311-025-10	1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2021
4	NDC: 81311-025-37	3785 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2021	09/30/2021

CLAYR 
citric acid, cinnamonoil spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81311-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CINNAMON OIL (UNII: E5GY4I6YCZ) (CINNAMON OIL - UNII:E5GY4I6YCZ)	CINNAMON OIL	1 g  in 1000 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	5 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	940 mL  in 1000 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81311-015-60	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2021
2	NDC: 81311-015-30	300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2021
3	NDC: 81311-015-10	1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2021
4	NDC: 81311-015-37	3785 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/2021	09/30/2021

Labeler - Sunbio Corporation (809434231)

Establishment
Name	Address	ID/FEI	Business Operations
Sunbio Corporation		809434231	manufacture(81311-015, 81311-025)

Revised: 12/2021

Document Id: d30a0f73-4c6c-9f05-e053-2995a90a50e4

34390-5

Set id: b6d727f2-29ff-3d0a-e053-2995a90a9217

Version: 2

Effective Time: 20211213