NATURES ANTIBAC PEPPERMINT- natures antibac peppermint 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 Peppermint Liquid Soap

Active Ingredient:

Thymus Vulgaris Oil (Thymol 0.15%)

Purpose:

Antibacterial

Warning:

Keep out of reach of children

Use:

For handwashing to help eliminate bacteria on skin

Warning:

For external use only

Instruct children on proper use.

Stop use and ask doctor if skin becomes irritated.

Directions:

Apply to wet hands, lather, and rinse.

Inactive Ingredients:

Aloe Barbadensis (Aloe) Leaf Juice*, Coco-Glucoside*, Copper PCA*, Decyl Glucoside, Glycereth-5 Lactate*, Glyceryl Oleate*, Hydrolized Oats*, Lactic Acid*, Mentha Piperita (Peppermint) Oil, PEG-150 Pentaerythrityl Tetrastearate, PPG-2 Hydroxyethyl Cocamide, Sodium Coco-Sulfate, Water

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NATURES ANTIBAC PEPPERMINT
natures antibac peppermint soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:28107-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.0024 kg in 1 kg

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.0025 kg in 1 kg
PEPPERMINT OIL (UNII: AV092KU4JH)	0.005 kg in 1 kg
COCO GLUCOSIDE (UNII: ICS790225B)	0.0065 kg in 1 kg
COPPER PIDOLATE (UNII: 497G7G1SL1)	0.0007 kg in 1 kg
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)	0.084 kg in 1 kg
GLYCERETH-5 LACTATE (UNII: Y0OF5SUB03)	0.01 kg in 1 kg
GLYCERYL OLEATE (UNII: 4PC054V79P)	0.0065 kg in 1 kg
AMINO ACIDS, OAT (UNII: NU3FAK86IP)	0.001 kg in 1 kg
LACTIC ACID (UNII: 33X04XA5AT)	0.02 kg in 1 kg
PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)	0.007 kg in 1 kg
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)	0.007 kg in 1 kg
SODIUM COCO-SULFATE (UNII: 3599J29ANH)	0.021 kg in 1 kg
WATER (UNII: 059QF0KO0R)	0.8264 kg in 1 kg

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:28107-010-12	0.355 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2012	05/29/2019
2	NDC:28107-010-11	0.946 kg in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2012	05/29/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/01/2012	05/29/2019

Labeler - CleanWell, LLC (079787350)

Registrant - CleanWell, LLC (079787350)

Name	Address	ID/FEI	Business Operations
Establishment
Thibiant International, Inc.		083913913	manufacture(28107-010)

Revised: 3/2018

Document Id: 67d6f7b9-3cbc-8308-e053-2991aa0a3af0

Set id: 4310a311-3eac-4f3a-876c-e82b85fd57c2

Version: 3

Effective Time: 20180320

CleanWell, LLC