Sarasota Memorial Amenity Kit
FDA Label NDC 59448-600

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Asp Global, Llc for the product Sarasota Memorial Amenity (NDC 59448-600). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, otc - keep out of reach of children, directions, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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)

Ethyl Alcohol 62%

Purpose

Anticavity

Antiseptic

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.

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

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.

Inactive Ingredients

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

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

Questions Or Comments?

Call toll-free 1-800-468-6502

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.

Other Information

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

Principal Display Panel - 10 G Tube Label

P1505037

Colgate®
Anticavity Toothpaste

Cavity
Protection

NET WT 10g
7
OTHER

Principal Display Panel (10 g Tube Label)

Principal Display Panel (10 g Tube Label)

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 (53 mL Bottle Label)

Principal Display Panel (53 mL Bottle Label)

Principal Display Panel - Kit Label

SARASOTA
MEMORIAL

HEALTH CARE SYSTEM

Contents/Origins:

1.9 fl. oz. Hand Sanitizer
Toothbrush, Sleep Mask, Ear Plugs, Facial Tissue, Paper
Bag 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

SARASOTA
MEMORIAL

HEALTH CARE SYSTEM

Item #: SARASOTA01
Description: AMENITY KIT, SARASOTA
MEM WELCOME
PO #:
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Qty: 30 KIT/CS
Carton #: XXX of XXX
Net Wt.: XX KG
Gross Wt.: XX KG
Cubic Dimensions: XX x XX x XX CM
Assembled in China

Components Made in China:

  • Hand Sanitizer
  • Toothbrush
  • Sleep Mask
  • Ear Plugs
  • Facial Tissue
  • Paper Bag
  • Kit Case
  • Component Made in Thailand:

    • Toothpaste
    • SARASOTA
      MEMORIAL

      HEALTH CARE SYSTEM

      Principal Display Panel (Kit Label)

      Principal Display Panel (Kit Label)

* Please review the disclaimer below.