IPANA WINTERGREEN FLUORIDE- sodium monofluorophosphate paste 
Maxill Inc.

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.

----------

Ipana Wintergreen Fluoride Toothpaste

Drug Facts

Active Ingredients

Sodium Monofluorophosphate 0.76% (Fluoride 0.1% w/w)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentaly swallowed get medical help or contact a Poison Control Center right away. external use only.

Directions

Inactive Ingredients

calcium carbonate, water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, carboxymethylcellulose, sodium benzoate, sodium saccharin

Product Label

ipana

Since 1901

Wintergreen

FLUORIDE

TOOTHPASTE

FIGHTS CAVITIES

NET WT. 0.66 OZ (19g)

ITEM 40515

Dist. by:

Maxill inc.

Cortland, OH, USA  44410

1-800-268-8633 www.maxill.com

Made in Malaysia

Label

IPANA WINTERGREEN FLUORIDE 
sodium monofluorophosphate paste
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69510-010
Route of Administration DENTAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color      Score     
Shape Size
Flavor WINTERGREEN Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:69510-010-19 1 in 1 BOX 01/05/2015
1 19 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 12/31/2014
Labeler - Maxill Inc. (079343581)
Establishment
Name Address ID/FEI Business Operations
AmLion Toothpaste Sdn. Bhd 652244161 manufacture(69510-010)

Revised: 12/2016
Document Id: 442e8091-cbe5-4c61-e054-00144ff8d46c
Set id: 5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0
Version: 3
Effective Time: 20161221
 
Maxill Inc.