Other
Instant Hand Antiseptic
Drug Facts
Distributed by:
ASP Global, LLC
3450 Atlanta Industrial Parkway
Atlanta, GA 30331
Colgate® Anticavity Toothpaste
Drug Facts
Instant Hand Antiseptic Gel
FDA Label NDC 59448-004
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 59448-004). 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.
Label Section Quick Index
Active Ingredient
Ethyl Alcohol 62%
Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)
Purpose
Antiseptic
Anticavity
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help.
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
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.
| 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 |
Other Information
Do not store above 110°F. May discolor some fabrics.
Inactive Ingredients
Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance.
dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin
Use
helps protect against cavities
Questions Or Comments?
Call toll-free 1-800-468-6502
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 - 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
EMORY
JOHNS CREEK
HOSPITAL
Item #: EJCKIT01
Description: AMENITY KIT,
EMORY JOHNS CREEK
PO #:
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Qty: 30 KIT/CS
Carton #: XXX of XXXX
Net Wt.: XX KG
Gross Wt.: XX KG
Cubic Dimensions: 54.0 x 19.0 x 27.0 CM
Assembled in China
Components Made in China:
- Alcohol and Fragrance Free Hand Sanitizer
- Lip Balm Ball
- Toothbrush
- Sleep Mask
- Ear Plugs
- Body Lotion
- Deodorant Stick
- Kit Case
- Toothpaste
Component Made in Thailand:
EMORY
JOHNS CREEK
HOSPITAL
Contents/Origins:
1.9 fl. oz. Alcohol and Fragrance Free Hand Sanitizer,
0.25 oz. net wt. Lip Balm Ball,
2 fl. oz. Body Lotion,
0.5 oz. net wt. Deodorant Stick,
Toothbrush, Sleep Mask, Ear Plugs, 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
EMORY
JOHNS CREEK
HOSPITAL
Principal Display Panel (Kit Label)
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