DR DEEP DEEP FRESH- glycerin paste, dentifrice
MineralHouse Corporation

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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Active Ingredient: Silicon Dioxide 4%, Glycerin 6.4%

Squeeze appropriate amount of toothpaste onto your toothbrush and gently brush your teeth with a short, vertical or circular motion

For brushing teeth

Purpose: Skin Protectant

Warnings:

- For external use only

- Do not use on wounds or damaged skin

When using this product, do not use other than directed

Stop use if allergic reaction or irritation occurs

Keep out of reach of children

- If swallowed, get medical help or contact a Poison Control Center immediately

Storage: Keep in a dry and cool place

Inactive Ingredients: Aluminum Chlorohydroxy Allantoinate, Aminocaproic Acid, D-Sorbitol Solution, Polyethylene Glycol 4000, stevgiol Glycoside, Xylitol, Citrus Paradisi (Grapefruit) Seed Extract, Camellia Sinensis Leaf Extract, Sodium Carboxymethyl Cellulose, Cacamidopropyl Betaine, L-Menthol, Mentha Piperita (Peppermint) Oil, Aqua

Box Label

DR DEEP DEEP FRESH
glycerin paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76015-110
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	7.68 g in 120 g

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	4.8 g in 120 g
ALCLOXA (UNII: 18B8O9DQA2)
AMINOCAPROIC ACID (UNII: U6F3787206)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
XYLITOL (UNII: VCQ006KQ1E)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LEVOMENTHOL (UNII: BZ1R15MTK7)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76015-110-01	1 in 1 PACKAGE	08/12/2016
1		120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/12/2016

Labeler - MineralHouse Corporation (557802539)

Registrant - MineralHouse Corporation (557802539)

Name	Address	ID/FEI	Business Operations
Establishment
MineralHouse Corporation		557802539	relabel(76015-110) , repack(76015-110)

Name	Address	ID/FEI	Business Operations
Establishment
Sangleaf Pharm., Co. Ltd.		689847343	manufacture(76015-110)