COOL MELON - allantoin cream 
Deb USA, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient

Allantoin, 0.5%

Purpose

Skin protectant

Uses

Helps relieve chapped or cracked skin

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

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.

Directions

Apply to clean hands

Rub in well

Re-apply after handwashing or as needed

Inactive Ingredients

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

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 

container label

COOL MELON 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-042
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11084-042-271000 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2010
Labeler - Deb USA, Inc. (607378015)
Establishment
NameAddressID/FEIBusiness Operations
Deb USA, Inc.607378015manufacture

Revised: 10/2010
Document Id: 49cc3124-4c50-41d7-9d72-ad30761c7b9b
Set id: 9df87983-deb7-409d-8bea-234160010b0a
Version: 1
Effective Time: 20101006
 
Deb USA, Inc.