IPANA WINTERGREEN FLUORIDE- sodium monofluorophosphate paste

Ipana Wintergreen Fluoride by

Drug Labeling and Warnings

Ipana Wintergreen Fluoride by is a Otc medication manufactured, distributed, or labeled by Maxill Inc., AmLion Toothpaste Sdn. Bhd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or doctor.
• Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
• Children under 2 years: Consult a dentist or doctor.

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

INGREDIENTS AND APPEARANCE

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)