COOL MELON- allantoin cream

Cool Melon by

Drug Labeling and Warnings

Cool Melon by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Allantoin, 0.5%

PURPOSE

Purpose

Skin protectant

INDICATIONS & USAGE

Uses

Helps relieve chapped or cracked skin

Helps prevent and protect from the drying effects of wind and cold weather

WARNINGS

Warnings

For external use only

When using this product avoid contact with the eyes.

In case of eye contact, flush with water.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Apply to clean hands

Rub in well

Re-apply after handwashing or as needed

INACTIVE INGREDIENT

Inactive Ingredients

Water, Cetyl Esters, Petrolatum, Isoproply Palmitate, Stearyl Alcohol, Ceteareth-20, Chloroxylenol, Carbomer, PEG-75 Lanolin, Hydroxyethylcellulose, Methylparaben, Ethanolamine, Propylparaben, Fragrance.

PRINCIPAL DISPLAY PANEL

Cool Melon

Medicated Skin Cream

Non-Greasy, Silicone-Free

Conditions and relieves dry, hard-working hands

deb

Proudly made in the USA by Deb

40227-00-100

1 Liter - 33.8 Fluid Ounces 

INGREDIENTS AND APPEARANCE

COOL MELON 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-042
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
CARBOMER 934 (UNII: Z135WT9208)
HYDROXYETHYL CELLULOSE (4000 CPS AT 1%) (UNII: ZYD53NBL45)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHANOLAMINE (UNII: 5KV86114PT)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-042-27	1000 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2010

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Deb USA, Inc.		607378015	manufacture