FDA Label for Sarasota Memorial Amenity

View Indications, Usage & Precautions

Sarasota Memorial Amenity 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.

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 - 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 - 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:

* Please review the disclaimer below.