CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZING WIPES cloth

CleanWell Natural Orange Vanilla Hand Sanitizing Wipes by

Drug Labeling and Warnings

CleanWell Natural Orange Vanilla Hand Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by CleanWell, LLC, Tufco LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Thymus Vulgaris Oil (Thymol 0.05%)

Purpose

Sanitizer

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - CleanWell, LLC (079787350)

Registrant - CleanWell, LLC (079787350)

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