Instant Hand Antiseptic
DRUG FACTS
Northside Hospital Grey Amenity Kit
FDA Label NDC 59448-213
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 Northside Hospital Grey Amenity Kit (NDC 59448-213). 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 instant hand antiseptic, otc - purpose, uses, warnings, when using the product, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Ethyl Alcohol I.P. : 70.0% v/v Gel base
Uses
Hand Sanitization to decrease bacteria on the skin.
For use when soap and water are not available.
Regular brushing with Fluoride toothpaste helps protect teeth roots against cavities.
Warnings
Flammable. Keep away from fire or flame.
For external use only. Recommended for repeated use.
When Using The Product
Do not use in or near the eyes.
In case of contact, rinse eyes thoroughly with water.
Otc - Keep Out Of Reach Of Children
Irritation or rash appears, Keep out of reach of children. If swallowed, get medical help or call a poison control center.
Keep out of reach of children under 6 years of age.
Directions
Not recommended for infants. Wet hands thoroughly with product & allow to self dry. Children under 6 years of agae should be supervised when using this product.
| Adults & 6+ Children | Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician | |
| Children under 6 yrs. | To minimize swallowing use a pea - sized amount and supervise brushing. | |
| Children under 2 yrs. | Ask a dentist or physician. | NDC NO. 84132-100-10 |
Other Information
Avoid freezing, Do not store above 40°C ( 104°F ).
Ingredients
Ultrez - 20. Glycerin, Propylene Glycol, Ethyl Alcohol, Aloe Vera Juice, Fragrance & Purified Water.
Other
DISTRIBUTED BY:
ASP GLOBAL, LLC
7800 THIRD FLAG PARKWAY,
AUSTELL, GA 30168, USA
Decure Toothpaste
Drug Facts
Active Ingredient
Sodium Monofluorophosphate 0.76%
Purpose
Anticavity (Total Fluoride Content - 1000 ppm Approx.)
Otc - Do Not Use
Don't use if irritation occurs and persists. If more than used for brushing is accidentally swallowed, get medical help, or contact a Poison Control Center right away.
Inactive Ingredients
Calcium Carbonate, Water, Sorbitol, Silica, Sodium Lauryl Sulphate, Flavor, Sodium Silicate, Tetra Sodium Pyrophosphate, Cellulose Gum, Xanthan Gum, Benzyl Alcohol, Sodium Saccharin, Sodium Benzoate
Principal Display Panel - 53 Ml Bottle Label
ASP
GLOBAL
INSTANT
Hand
Antiseptic
70.0% Ethyl Alcohol
1.9 FL OZ / 53 mL
Principal Display Panel (53 mL Bottle Label)
Principal Display Panel - 10 G Tube Label
DeCure
Net Weight 10gms / 0.35oz
Toothpaste
With Fluoride Anticavity Protection
Principal Display Panel (10 g Tube Label)
Principal Display Panel - Kit Label
NORTHSIDE
HOSPITAL
Creating a Healing Environment
We provide our patients with the essentials
they need to stay well rested.
This is an important part of healing,
both here and at home.
Storage: Do not store above 40°C (104°F).
Avoid direct exposure to sunlight.
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Contents/Origins:
2.0 fl. oz. Shampoo
2.0 fl. oz. Hair Conditioner
2.0 fl. oz. Shower Gel
2.0 fl. oz. Body Lotion
0.15 oz. net wt. Lip Balm
1.9 fl. oz. Hand Sanitizer
Toothbrush, Toothpaste and Kit Case: Made in India
Spiral Hair Tie: Made in China
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Distributed by:
ASP Global, LLC
7800 Third Flag Parkway,
Austell, GA 30168, USA
REV 00
NORTHSIDE
HOSPITAL
Item #: NSAMK-05
Description: KIT, NORTHSIDE GREY AMENITY
PO #: XXXXXXXXX
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Qty: 20 BAGS/CS
Carton #: XXXX of XXXX
Net Wt.: XX.X KG
Gross Wt.: XX.X KG
Cubic Dimensions: 42.0 x 30.0 x 28.0 CM
Components made in India:
- Shampoo
- Hair Conditioner
- Shower Gel
- Body Lotion
- Toothbrush
- Toothpaste
- Hand Sanitizer
- Lip Balm
- Kit Case
- Spiral Hair Tie
Component made in China:
Assembled in India
NSAMK-05-MC REV 00
NORTHSIDE HOSPITAL
Principal Display Panel (Kit Label)
* Please review the disclaimer below.
