Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

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

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions


adults and children 2 years of age and older	brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years	use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years	ask a dentist or physician

Inactive ingredients

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

Call to-free 1-800-468-6502

Drug Facts

Active Ingredient

Ethyl Alcohol 75% (v/v)

Purpose

Antiseptic

Uses

To help reduce bacteria on the skin.

Warnings

For external use only.
Do not dispose of wipes in flush toilets.

Flammable

Keep away from fire or flame.

When using this product

avoid contact with eyes.
If contact occurs, rinse thoroughly with water.

Stop using and ask a doctor if

irritation or redness develops and lasts.

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

Appyl to hands or surface.
No rinsing required.
Discard after use.

Other Information

Store below 110°F (43°C).
May discolor certain fabrics or surfaces.

Inactive ingredients

Aqua (Water), Glycerin, Polyquaternium-37, Melaleuca Alternifolia Leaf Oil.

Package Labeling:69491-037-01

Kit3 Kit02

Package Labeling:42555-060-94

Tube

Package Labeling:69491-035-01

Label0

UNITED AIRLINES UPP KIT
sodium monofluorophosphate, alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69491-037

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69491-037-01	1 in 1 KIT	02/15/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	5 g
Part 2	1 PATCH	5 mL

Part 1 of 2

COLGATE ANTICAVITY
sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC:42555-060
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42555-060-94	5 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	part355	02/15/2022

Part 2 of 2

SANITIZER WIPE IN SACHET
alcohol cloth

Product Information
Item Code (Source)	NDC:69491-035
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TEA TREE OIL (UNII: VIF565UC2G)

#	Item Code	Package Description
Packaging
1	NDC:69491-035-01	1 in 1 PACKAGE
1		5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/15/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part355	02/15/2022

Labeler - Buzz Export Services Pty Ltd (Buzz Products) (747317902)

United Airlines UPP Kit

Drug Facts

Active ingredient

Purpose

Use

Warnings

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

Directions

Inactive ingredients

Questions or comments?

Drug Facts

Active Ingredient

Purpose

Uses

Warnings

When using this product

Stop using and ask a doctor if

Keep out of reach of children

Directions

Other Information

Inactive ingredients

Package Labeling:69491-037-01

Package Labeling:42555-060-94

Package Labeling:69491-035-01