Englewood Amenity Kit
FDA Label NDC 59448-400

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 Englewood Amenity (NDC 59448-400). 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, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Instant Hand Antiseptic

Drug Facts

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

Colgate® Anticavity Toothpaste

Drug Facts

Manufactured by:

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

Active Ingredient

Benzalkonium Chloride 0.095%

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

Purpose

Antiseptic

Anticavity

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.

Otc - Keep Out Of Reach Of Children

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

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

Rub dime sized amount between hands until dry.

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

Inactive Ingredients

Water, Polyquatemium-37, Glycerin, Propylene Glycol, Methylisothiazolinone, Trithanolamine, Fragrance.

dicalcium phosphate dihydrate, aqua(water), sorbitol, sodium lauryl sulfate, aroma(flavour), cellulose gum, tetrasodium pyrophosphate, sodium saccharin, limonene

Use

helps protect against cavities

Questions Or Comments?

Call toll-free 1-800-468-6502

Principal Display Panel - 53 Ml Bottle Label

ENGLEWOOD
HOSPITAL AND MEDICAL CENTER

Instant Hand Antiseptic

Alcohol Free

Your hospital for life.

1.9 FL OZ / 53 mL

Distributed by:
ASP Global, LLC
3450 Atlanta Industrial Parkway
Atlanta, GA 30331
Rev 05-2018

Principal Display Panel (53 mL Bottle Label)

Principal Display Panel (53 mL Bottle Label)

Principal Display Panel - 10 G Tube Label

Colgate®
Anticavity Toothpaste

Cavity
Protection

Principal Display Panel (10 g Tube Label)

Principal Display Panel (10 g Tube Label)

Principal Display Panel - Kit Label

ENGLEWOOD
HOSPITAL AND MEDICAL CENTER

Your hospital for life.

Contents/Origins:

2.0 fl.oz. G&S Shampoo/Conditioner
2.0 fl.oz. G&S Body Wash
2.0 fl.oz. G&S Body Lotion
2.0 fl.oz. Alcohol-Free Mouthwash
0.15 oz. net wt. Lip Balm
0.1oz. G&S Deodorant
1.9 fl.oz. Alcohol-Free Hand Sanitizer
Toothbrush Case, Toothbrush, Hairbrush, Nail File, Eye Mask,
Ear Plugs, Ear Phones, 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

ENGLEWOOD
HOSPITAL AND MEDICAL CENTER

Item #: ENGLWD11
Description: Amenity Kit, Englewood

PO #:
Lot #:
XMMDDFC
Exp: YYYY-MM-DD
Qty: 20 KIT/CS
Carton #: X of XX
Net Wt.: XX KG
Gross Wt.: XX KG
Cubic Dimensions: NN x NN x NN CM

Assembled in China

Components Made in China:

  • Shampoo/Conditioner
  • Body Wash
  • Body Lotion
  • Alcohol-Free Mouthwash
  • Lip Balm
  • Deodorant
  • Alcohol-Free Hand Sanitizer
  • Toothbrush Case
  • Toothbrush
  • Hairbrush
  • Nail File,
  • Eye Mask,
  • Ear Plugs
  • Ear Phones
  • Kit Case
  • Component Made in Thailand:

    • Toothpaste
    • ENGLEWOOD
      HOSPITAL AND MEDICAL CENTER

      Your hospital for life.

      Principal Display Panel (Kit Label)

      Principal Display Panel (Kit Label)

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