IASOBETIC ALLANTOIN SKIN PROTECTANT- allantoin cream 
IASOBETIC WOUND CARE CORP.

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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IASOBETIC Allantoin Skin Protectant Cream

Drug Facts

Active ingredient

Allantoin 2%

Purpose

Skin Protectant

Use

Warnings

For external use only

When using this product

  • do not get into eyes.

Stop use and ask a doctor if

  • condition worsens
  • symptoms last 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 Poison Control Center right away.

Directions

apply as needed

Other information

Store at room temperature 15-27° C (59-80° F)

Inactive ingredients

Aloe vera leaf juice, shea butter, turmeric, coconut oil, carbomer, cetyl alcohol, dimethicone, diatomite, glucosamine, glycol stearate SE, EDTA disodium, ethylhexylglycerin, glycerin, isopropyl myristate, laureth-8, lecithin, gotu kola, stearic acid, plantain leaf extract powder, phenoxyethanol, hydrogenated polydecene, purified water, pullulan, sodium acrylate/sodium acryloyldimethyl taurate copolymer, sclerotium gum, triethanolamine, xanthan gum.

Package Labeling:

Outer LabelInner Label

IASOBETIC ALLANTOIN SKIN PROTECTANT 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72904-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SHEA BUTTER (UNII: K49155WL9Y)  
TURMERIC (UNII: 856YO1Z64F)  
COCONUT OIL (UNII: Q9L0O73W7L)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
GLUCOSAMINE (UNII: N08U5BOQ1K)  
GLYCOL STEARATE SE (UNII: 6YLY96TQL6)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LAURETH-8 (UNII: QU7U88D04I)  
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
TROLAMINE (UNII: 9O3K93S3TK)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72904-001-501 in 1 BOX03/01/2020
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2020
Labeler - IASOBETIC WOUND CARE CORP. (115173710)

Revised: 2/2020
Document Id: 9e8c6d1c-ba65-6a7c-e053-2995a90a517d
Set id: 5b2cf65a-e6ba-4d0b-857e-03f1eecaec72
Version: 2
Effective Time: 20200214
 
IASOBETIC WOUND CARE CORP.