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.

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Instant Hand Antiseptic

Drug Facts

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

Colgate® Anticavity Toothpaste

Drug Facts


Active Ingredient



Ethyl Alcohol 62%

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


Purpose



Antiseptic

Anticavity


Uses



For hand washing to decrease bacteria on the skin.

Recommended for repeated use.


Warnings



Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.


Otc - When Using



When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.


Otc - Stop Use



Stop use and ask a doctor if irritation or rash appears and lasts.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help.

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



Not recommended for infants.

Wet hands thoroughly with product and allow to dry without wiping.

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

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

Other Information



Do not store above 110°F. May discolor some fabrics.


Inactive Ingredients



Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance.

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


Use



helps protect against cavities


Questions Or Comments?



Call toll-free 1-800-468-6502


Principal Display Panel - 53 Ml Bottle Label



ASP
MEDICAL

Instant Hand Antiseptic

62% w/w Ethyl Alcohol

1.9 FL OZ / 53 mL

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

Rev 00


Principal Display Panel - 10 G Tube Label



P1505037

Colgate®
Anticavity Toothpaste

Cavity
Protection

NET WT 10g

7
OTHER


Principal Display Panel - Kit Label



EMORY
JOHNS CREEK
HOSPITAL

Item #: EJCKIT01
Description: AMENITY KIT,
EMORY JOHNS CREEK
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: 54.0 x 19.0 x 27.0 CM

Assembled in China

Components Made in China:

  • Alcohol and Fragrance Free Hand Sanitizer
  • Lip Balm Ball
  • Toothbrush
  • Sleep Mask
  • Ear Plugs
  • Body Lotion
  • Deodorant Stick
  • Kit Case
  • Component Made in Thailand:

    • Toothpaste
    • EMORY
      JOHNS CREEK
      HOSPITAL

      Contents/Origins:

      1.9 fl. oz. Alcohol and Fragrance Free Hand Sanitizer,
      0.25 oz. net wt. Lip Balm Ball,
      2 fl. oz. Body Lotion,
      0.5 oz. net wt. Deodorant Stick,
      Toothbrush, Sleep Mask, Ear Plugs, 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

      EMORY
      JOHNS CREEK
      HOSPITAL


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