INTERNATIONAL FIRST AMENITY KIT- ethyl alcohol, sodium fluoride
BUZZ PRODUCTS (HK) CO. LIMITED

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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International First Amenity Kit

HAND CLEANSER RINSE-FREE HAND CLEANSING GEL

Drug Facts

Active Ingredients

Ethyl Alcohol 62%

Purpose

Antiseptic

Use

Hand cleanser for decreasing bacteria on hands.

Warnings

For external use only

Do not use

in the eyes. In case of contact, rinse eyes thoroughly with water.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor

if irritation and/or redness develops.

Highly Flammable.

Keep away from fire or flame.

Directions

Wet hands thoroughly with product. Briskly, rub hands together until dry. Supervise children in the use of this product.

Inactive Ingredients

Aqua (Water), Glycerol, Acrylic Polymer, Triethanolamine, Parfum (Fragrance), Vitamin E, Aloe.

Other Information

May discolor certain fabrics. Store at 20 to 25 degrees C (68 to 77 degrees F).

Crest CAVITY PROTECTION Regular Paste

Drug Facts

Active ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warnings

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

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

Directons

adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
do not swallow
to minimize swallowing use a pea-sized amount in children under 6
supervise children's brushing until good habits are established
children under 2 yrs.: ask a dentist

Inactive ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, flavor, sodium phosphate, cellulose gum, carbomer, sodium saccharin, titanium dioxide, blue 1

Questions?

1-800-492-7378

Package Label

PolyBag Labeling:

Bag

Bottle Labeling:

Bottle

Package Labeling

Toothpaste

INTERNATIONAL FIRST AMENITY KIT
ethyl alcohol, sodium fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70402-004

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70402-004-01	1 in 1 BAG; Type 1: Convenience Kit of Co-Package	02/01/2016	12/18/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE	20 mL
Part 2	1 TUBE	24 g

Part 1 of 2

HAND CLEANSER
ethyl alcohol gel

Product Information
Item Code (Source)	NDC:42086-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	620 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALOE (UNII: V5VD430YW9)

#	Item Code	Package Description
Packaging
1	NDC:42086-001-01	1 in 1 BAG
1		20 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/01/2016	12/31/2020

Part 2 of 2

CREST CAVITY PROTECTION REGULAR
sodium fluoride paste, dentifrice

Product Information
Item Code (Source)	NDC:37000-005
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PHOSPHATE (UNII: SE337SVY37)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-005-08	24 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	02/01/2016	12/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/01/2016	12/18/2018

Labeler - BUZZ PRODUCTS (HK) CO. LIMITED (663516515)

Revised: 12/2018

Document Id: 7d4ee486-4916-2808-e053-2991aa0a3740

Set id: 7684a20c-dea4-4560-9673-ceeae459b1a7

Version: 5

Effective Time: 20181218

BUZZ PRODUCTS (HK) CO. LIMITED