FDA Label for Instant Hand Antiseptic

View Indications, Usage & Precautions

Instant Hand Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Asp Global, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Colgate® Anticavity Toothpaste

Drug Facts

Manufactured by:
COLGATE-PALMOLIVE (THAILAND) Limited, Chonburi 20000, Thailand.

Instant Hand Antiseptic

Drug Facts

Distributed by:
ASP Global, LLC
3450 Atlanta Industrial Parkway
Atlanta, GA 30331


Active Ingredient



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

Benzethonium Chloride 0.095%


Purpose



Anticavity


Use



helps protect against cavities


Otc - Keep Out Of Reach Of Children



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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.


Directions



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

Rub dime sized amount between hands until dry.

Children under 6 years of age should be supervised when using this product.


Inactive Ingredients



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

Water, Polyquaternium-37, Glycerin, Propylene Glycol, Methylisothiazolinone, Triethanolamine.


Questions Or Comments?



Call toll-free 1-800-468-6502


Propose



Antiseptic


Uses



To help reduce bacteria on hands.


Warnings



For external use only.


Otc - When Using



When using this product avoid contact with eyes and lips. If contact occurs, rinse with water.


Otc - Stop Use



Stop use and ask a doctor if irritation or redness develops.


Principal Display Panel - 10 G Tube Label



Colgate®
Anticavity Toothpaste

Cavity
Protection


Principal Display Panel - 53 Ml Bottle Label



ASP
MEDICAL

Instant Hand Antiseptic
Alcohol & Fragrance Free

1.9 FL OZ / 53 mL

Distributed by:
ASP Global, LLC
3450 Atlanta Industrial Parkway
Atlanta, GA 30331

Rev 00


Principal Display Panel - Kit Label



We strive to provide a quiet environment for you
to rest in during your stay. This Welcome Packet
contains some items that are helpful in reducing
hospital noise.

The best healing happens in a quiet environment.

You can help by:

  • Using a headset when watching TV
  • Keeping cell phones on vibrate
  • Speaking softly
  • Asking family and friends to visit two at a time
  • We are honored to care for you.

    Contents/Origins:
    1.9 fl. oz. Alcohol and Fragrance Free Hand Sanitizer,
    0.15 oz. net wt. Lip Balm,
    Toothbrush, Sleep Mask, Ear Plugs, Notebook, Pen and
    Kit Case: Made in China
    Toothpaste: Made in Thailand

    Lot #: XMMDDFC
    Exp: YYYY-MM-DD

    Distributed by:
    ASP Global, LLC
    3450 Atlanta Industrial Parkway, Atlanta, GA 30331

    REV 00

    THE
    University of Vermont
    MEDICAL CENTER

    Item #: UNVMC01
    Description: AMENITY KIT, UVMC,
    GREEN, ZIPPERED
    PO #:
    Lot #: XMMDDFC
    Exp: YYYY-MM-DD
    Qty: 30 KIT/CS
    Carton #: XXX of XXXX
    Net Wt.: XX KG
    Gross Wt.: XX KG
    Cubic Dimensions: 57.0 x 17.0 x 27.0 CM

    Components Made in China:

    • Alcohol and Fragrance Free Hand Sanitizer
    • Lip Balm
    • Toothbrush
    • Sleep Mask
    • Ear Plugs
    • Notebook
    • Pen
    • Kit Case
    • Component Made in Thailand:

* Please review the disclaimer below.