IASOBETIC ALLANTOIN SKIN PROTECTANT- allantoin cream

IASOBETIC Allantoin Skin Protectant by

Drug Labeling and Warnings

IASOBETIC Allantoin Skin Protectant by is a Otc medication manufactured, distributed, or labeled by IASOBETIC WOUND CARE CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Allantoin 2%

Purpose

Skin Protectant

Use

• temporarily protects minor:
• cuts
• scrapes
• burns
• helps prevent and temporarily protects chafed, chapped or cracked skin

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:

INGREDIENTS AND APPEARANCE

IASOBETIC ALLANTOIN SKIN PROTECTANT 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72904-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72904-001-50	1 in 1 BOX	03/01/2020
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/01/2020

Labeler - IASOBETIC WOUND CARE CORP. (115173710)