CLEANWELL NATURAL ANTIBACTERIAL FOAMING ORANGE VANILLA- cleanwell natural antibacterial foaming orange vanilla 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.

----------

CleanWell Orange Vanilla Foaming Handsoap

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 * , Citrus Aurantium Dulcis (Orange) Oil, Copper PCA*, Glycolic Acid*, Hydrolyzed Oats*, Origanum Vulgare Oil, Sodium Citrate, Sodium Decylglucosides Hydroxypropyl Sulfonate, Sodium Methyl 2-Sulfolaurate, Sulfated Castor Oil Methyl Ester, Vanilla Planifolia (Vanilla) Fruit Extract, Water.

ovsmalloz.jpg

ovsmalloz.jpg

ovbigoz.jpg

ovbigoz.jpg

CLEANWELL NATURAL ANTIBACTERIAL FOAMING ORANGE VANILLA 
cleanwell natural antibacterial foaming orange vanilla soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28107-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.0004   in 1 kg
Inactive Ingredients
Ingredient NameStrength
THYME OIL (UNII: 2UK410MY6B) 0.00024   in 1 kg
OREGANO (UNII: 0E5AT8T16U) 0.0001 kg  in 1 kg
ORANGE OIL (UNII: AKN3KSD11B) 0.001 kg  in 1 kg
VANILLA (UNII: Q74T35078H) 0.005 kg  in 1 kg
SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV) 0.02 kg  in 1 kg
GLYCOLIC ACID (UNII: 0WT12SX38S) 0.02 kg  in 1 kg
SODIUM DECYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: 55P9UXJ9C3) 0.012 kg  in 1 kg
CASTOR OIL (UNII: D5340Y2I9G) 0.01 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) 0.89017 kg  in 1 kg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:28107-004-060.28 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/200705/29/2019
2NDC:28107-004-110.946 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(28107-004)

Revised: 3/2018
Document Id: 67d6f7b9-3c9b-8308-e053-2991aa0a3af0
Set id: d7cac194-6ced-429a-8645-bd450329d674
Version: 3
Effective Time: 20180320
 
CleanWell, LLC