CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZING WIPES- cleanwell natural orange vanilla hand sanitizing wipes cloth
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 Natural Orange Vanilla Hand Sanitizing Wipes

Active Ingredient:

Thymus Vulgaris Oil (Thymol 0.05%)

Purpose

Sanitizer

Use:

To sanitize hands

Warning:

For external use only

Instruct children on proper use.

Stop use and ask a doctor if skin becomes irritated

Directions:

Apply thoroughly to hands and face as desired. Close lid between uses to retain moisture. Do not flush wipes. To Dispense: Lift tab at front of lid to open. Pull up corner of center sheet adn thread through dispenser slit in lid. Pull out exposed wipe at 45 angle and snap off. The next wipe is ready for dispensing.

Inactive Ingredients:

Aloe Barbadensis (Aloe) Leaf Juice*, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, Copper PCA*, Hydrolyzed Oats*, Origanum Vulgare (Oregano) Oil, Sodium Citrate, Sodium Coco Sulfate, Sodium Decylglucosides Hydroxypropyl Sulfonate, Vanilla Planifolla (Vanilla) Fruit Extract, Water

Natural Hand Sanitizing Wipes

CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZING WIPES
cleanwell natural orange vanilla hand sanitizing wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:28107-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.0005 kg in 1 kg

Ingredient Name	Strength
Inactive Ingredients
THYME OIL (UNII: 2UK410MY6B)	0.0003 kg in 1 kg
OREGANO LEAF OIL (UNII: 7D0CGR40U1)	0.0001 kg in 1 kg
ORANGE OIL (UNII: AKN3KSD11B)	0.001 kg in 1 kg
VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)	0.002 kg in 1 kg
SODIUM DECYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: 55P9UXJ9C3)	0.0016 kg in 1 kg
SODIUM COCO-SULFATE (UNII: 3599J29ANH)	0.0032 kg in 1 kg
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.00046 kg in 1 kg
SODIUM CITRATE (UNII: 1Q73Q2JULR)	0.0007 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
WATER (UNII: 059QF0KO0R)	0.98656 kg in 1 kg

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:28107-007-09	0.16952 kg in 1 CANISTER; Type 0: Not a Combination Product	06/15/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	06/15/2010

Labeler - CleanWell, LLC (079787350)

Registrant - CleanWell, LLC (079787350)

Name	Address	ID/FEI	Business Operations
Establishment
Tufco LP		079862872	manufacture(28107-007)