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International First Amenity Kit

Medically reviewed on December 30, 2017

Dosage form: kit
Ingredients: ALCOHOL 620mg in 1mL; SODIUM FLUORIDE 1.5mg in 1g
Labeler: BUZZ PRODUCTS (HK) CO. LIMITED
NDC Code: 70402-004

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.

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:

Bottle Labeling:

Package Labeling

INTERNATIONAL FIRST AMENITY KIT 
ethyl alcohol, sodium fluoride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70402-004
Packaging
#Item CodePackage Description
1NDC:70402-004-011 KIT in 1 BAG
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 20 mL
Part 21 TUBE 24 g
Part 1 of 2
HAND CLEANSER 
ethyl alcohol gel
Product Information
Item Code (Source)NDC:42086-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL620 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
TROLAMINE 
.ALPHA.-TOCOPHEROL 
ALOE 
Packaging
#Item CodePackage Description
1NDC:42086-001-011 BOTTLE in 1 BAG
120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/01/201612/31/2020
Part 2 of 2
CREST CAVITY PROTECTION REGULAR 
sodium fluoride paste, dentifrice
Product Information
Item Code (Source)NDC:37000-005
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
HYDRATED SILICA 
SODIUM LAURYL SULFATE 
SODIUM PHOSPHATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SACCHARIN SODIUM 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
Product Characteristics
ColorblueScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:37000-005-0824 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/201612/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/01/201612/31/2020
Labeler - BUZZ PRODUCTS (HK) CO. LIMITED (663516515)

 
BUZZ PRODUCTS (HK) CO. LIMITED

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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