HEALING CVS- allantoin - 0.5% gel 
CVS

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                            Purpose

Allantoin 0.5%.................................Skin Protectant

Uses

 temporarily protects and helps relieve chapped or cracked skin

Warning

For external use only.
Do not use on • deep puncture wounds• animal bites • serious burns

When using this product • do not get into eyes

Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions • Apply as needed

Other information Store at room temperature

Inactive ingredients

Water, Glycerin, Avena Sativa (Oat) Kernel Extract, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Propylene Glycol, Beta-Glucan, 1,2-Hexanediol, Caprylyl Glycol, Glyceryl Acrylate/Acrylic Acid Copolymer, Sorbitol, Lecithin, Xanthan Gum, Oleic  Acid, Iron Oxide, Sodium Carbomer, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin

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HEALING  CVS
allantoin - 0.5% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-436
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
OAT (UNII: Z6J799EAJK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHAMOMILE (UNII: FGL3685T2X)  
Propylene Glycol (UNII: 6DC9Q167V3)  
CURDLAN (UNII: 6930DL209R)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Sorbitol (UNII: 506T60A25R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Xanthan Gum (UNII: TTV12P4NEE)  
Oleic Acid (UNII: 2UMI9U37CP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-436-04113 g in 1 JAR; Type 0: Not a Combination Product11/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/30/2015
Labeler - CVS (062312574)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(59779-436) , label(59779-436)

Revised: 12/2017
Document Id: acca9764-5c12-4bf5-a1c8-6d31d8121361
Set id: 482e9de7-0086-46fe-a1ae-3c35bff82cd2
Version: 2
Effective Time: 20171208
 
CVS