CleanAF Toothpaste

CLEANAFNATURALANTICAVITYTOOTHPASTE- sodium fluroide paste, dentrifice paste
CLEANAF GLOBAL LIMITED LIABILITY COMPANY

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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CleanAF Toothpaste

Toothpaste

Sodium Fluoride 0.22% (0.10% w/v fluoride ion)

Hydrated Silica, sodium benzoate, sodium lauryl sulfate, water, flavor, sorbitol, CMC, xantham gum, sodium phytate, sodium saccharin, titanium dioxide, glycerin

Anticavity

Do not swallow

CLEANAFNATURALANTICAVITYTOOTHPASTE
sodium fluroide paste, dentrifice paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71603-1700
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.22 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
PHYTATE SODIUM (UNII: 88496G1ERL)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71603-1700-0	142 g in 1 TUBE; Type 0: Not a Combination Product	07/17/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	07/17/2017

Labeler - CLEANAF GLOBAL LIMITED LIABILITY COMPANY (080739804)

Registrant - CLEANAF GLOBAL LIMITED LIABILITY COMPANY (080739804)

Name	Address	ID/FEI	Business Operations
Establishment
CLEANAF GLOBAL LIMITED LIABILITY COMPANY		080739804	label(71603-1700)