DEFLAME- allantoin cream

DeFlame by

Drug Labeling and Warnings

DeFlame by is a Otc medication manufactured, distributed, or labeled by Noon Aesthetics M.R. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Allantoin 0.5%

Purpose

Skin Protectant

Uses

• Temporarily protects minor: skin irritation, cuts, scrapes, burns and helps protect and relieve chafed, chapped or cracked skin.

Warnings

For external use only.

Do not use on

• deep or puncture wounds, animal bites, serious burns.

When using this product

• avoid contact with eyes. In case of eye contact, flush with water.

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.

Directions

• Apply as needed.

Inactive Ingredients

Aqua, Propylene Glycol, Glycerin, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Polydimethylsiloxane, Cetyl Alcohol, Glyceryl Stearate, Propanediol, Dipotassium Glycyrrhizate, Polysorbate 20, PEG-40 Stearate, Laureth-4, Porphyridium Polysaccharide, Arnica Montana Flower Extract, sh-Oligopeptide-1 (EGF), sh-Oligopeptide-2 (IGF-1), sh-Polypeptide-1 (bFGF), sh-Polypeptide-9 (VEGF), sh-Polypeptide-11 (FGF-1), Bacillus/Folic Acid Ferment Filtrate Extract, Octyldodecyl Xyloside, Butylene Glycol, Sodium Hyaluronate, 1,2-Hexanediol, Acetyl Glutamine, Octyldodecanol, PEG-30 Dipolyhydroxystearate, Sorbitan Tristearate, Lecithin, Phenoxyethanol, Benzyl Alcohol, Caprylyl Glycol, Potassium Sorbate, Disodium EDTA, Sodium Benzoate.

Questions or comments?

Visit noonaesthetics.com or call Toll Free 1.833.666.6246

SPL UNCLASSIFIED SECTION

Dist by NOON Aesthetics
TLV, 62153

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

noon
AESTHETICS

DeFlame
SKIN PROTECTANT

+ DERMSHIELD™

50 ml / 1.75 Fl. Oz. e

INGREDIENTS AND APPEARANCE

DEFLAME 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78863-1270
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
STRONTIUM CHLORIDE HEXAHYDRATE (UNII: O09USB7Z44)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LAURETH-4 (UNII: 6HQ855798J)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ACEGLUTAMIDE (UNII: 01J18G9G97)
OCTYLDODECANOL (UNII: 461N1O614Y)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78863-1270-1	1 in 1 CARTON	10/01/2023
1		50 mL 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	part352	10/01/2023

Labeler - Noon Aesthetics M.R. Ltd (600185560)

Establishment
Name	Address	ID/FEI	Business Operations
Noon Aesthetics M.R. Ltd		600185560	MANUFACTURE(78863-1270)