CLEANWELL NATURAL ANTIBACTERIAL FOAMING LAVENDER- cleanwell natural antibacterial foaming lavender soap 
CleanWell, LLC

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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CleanWell Lavender Absolute Natural Antibacterial Foaming Soap

Active Ingredient:

Thymus Vulgaris Oil (Thymol 0.04%)

Purpose

Antibacterial

Use:

For handwashing to help eliminate bacteria on skin.

Warning:

For external use only

Instruct children on proper use.

Stop use and ask a doctor if skin becomes irritated

Directions:

Apply to wet hands, lather, and rinse.

Inactive Ingredients:

Aloe Barbadensis (Aloe) Leaf Juice*, Camellia Sinensis (White Tea) Leaf Extract*, Copper PCA*, Glycolic Acid*, Hydrolyzed Oats*, Lavandula Angustifolia (Lavender) Oil, Origanum Vulgare Oil, Sodium Citrate, Sodium Decylglucosides Hydroxypropyl Sulfonate, Sodium Methyl 2-Sulfolaurate, Sulfated Castor Oil Methyl Ester, Water, Singiber Officinale (Ginger) Root Oil

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CLEANWELL NATURAL ANTIBACTERIAL FOAMING LAVENDER 
cleanwell natural antibacterial foaming lavender soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28107-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.0004 kg  in 1 kg
Inactive Ingredients
Ingredient NameStrength
THYME OIL (UNII: 2UK410MY6B) 0.00024   in 1 kg
OREGANO LEAF OIL (UNII: 7D0CGR40U1) 0.001 kg  in 1 kg
LAVENDER OIL (UNII: ZBP1YXW0H8) 0.002 kg  in 1 kg
GINGER OIL (UNII: SAS9Z1SVUK) 0.001 kg  in 1 kg
SODIUM DECYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: 55P9UXJ9C3) 0.012 kg  in 1 kg
SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV) 0.02 kg  in 1 kg
CASTOR OIL (UNII: D5340Y2I9G) 0.01 kg  in 1 kg
GLYCOLIC ACID (UNII: 0WT12SX38S) 0.02 kg  in 1 kg
SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.0375 kg  in 1 kg
COPPER (UNII: 789U1901C5) 0.00008 kg  in 1 kg
AMINO ACIDS, OAT (UNII: NU3FAK86IP) 0.001 kg  in 1 kg
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0025 kg  in 1 kg
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) 0.00001 kg  in 1 kg
WATER (UNII: 059QF0KO0R) 0.89227 kg  in 1 kg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:28107-005-060.28 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/200705/29/2019
2NDC:28107-005-110.946 kg in 1 BOTTLE; Type 0: Not a Combination Product11/01/200705/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/01/200705/29/2019
Labeler - CleanWell, LLC (079787350)
Registrant - CleanWell, LLC (079787350)
Establishment
NameAddressID/FEIBusiness Operations
Thibiant International, Inc.083913913manufacture(28107-005)

Revised: 3/2018
 
CleanWell, LLC