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.
Instant Hand Antiseptic Gel
FDA Label NDC 59448-002
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 for the product Instant Hand Antiseptic (NDC 59448-002). 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, propose, 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.
Label Section Quick Index
Active Ingredient
Benzalkonium Chloride 0.095%
Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)
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.
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 older | brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician |
| children 2 to 6 years | use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) |
| children under 2 years | ask a dentist or physician |
Inactive Ingredients
Water, Polyquaternium-37, Glycerin, Propylene Glycol, Methylisothiazolinone, Trithanolamine.
dicalcium phosphate dihydrate, aqua(water), sorbitol, sodium lauryl sulfate, aroma(flavour), cellulose gum, tetrasodium pyrophosphate, sodium saccharin, limonene
Purpose
Anticavity
Use
helps protect against cavities
Questions Or Comments?
Call toll-free 1-800-468-6502
Principal Display Panel - 53 Ml Bottle Label
ENGLEWOOD
HEALTH
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 02
Principal Display Panel (53 mL Bottle Label)
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 - Kit Label
ENGLEWOOD
HEALTH
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, Comb, Deck of Playing Card,
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
HEALTH
Item #: ENGLWD2
Description: Amenity Kit,
Englewood Mesh
PO #:
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Qty: 20 KIT/CS
Carton #: XX of XX
Net Wt.: XX.X KG
Gross Wt.: XX.X KG
Cubic Dimensions: XX x XX x XX 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
- Comb
- Deck of Playing Card
- Toothpaste
Component Made in Thailand:
ENGLEWOOD
HOSPITAL AND MEDICAL CENTER
Your hospital for life.
Principal Display Panel (Kit Label)
* Please review the disclaimer below.
