BURN RELIEF- allantoin, lidocaine, menthol cream

Burn Relief by

Drug Labeling and Warnings

Burn Relief by is a Otc medication manufactured, distributed, or labeled by HUMN Pharmaceuticals Inc, Delta Pharma Inc, Delta Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Allantoin 1.5% (w/w)

Lidocaine Hydrochloride 4.0% (w/w)

Menthol 1.0% (w/w)

PURPOSE

Purpose

Skin protectant

Anesthetic

Analgesic, anesthetic, and antipruritic

INDICATIONS & USAGE

Uses

Temporary relief of pain associated with:

▪ minor burns ▪ minor skin irritations

Temporary protection of minor skin irritations

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use

in large quantities, particularly:

over raw surfaces over blistered areas

ASK DOCTOR

Ask a doctor before use

if child is under 2 years of age, and use only as directed

WHEN USING

When using this product

avoid contact with eyes; if this happens, rinse thoroughly with water

STOP USE

Stop use and ask a doctor

condition worsens if symptoms persist for more than 7 days

clear up and occur again within a few days you experience: pain, swelling, or blistering

you experience: weakness, confusion, headache, difficulty breathing, or any unusual symptoms

you experience: pale, grey or blue-coloured skin, lips, or nail beds

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get

medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

INFORMATION FOR PATIENTS

Other information

do not use if seal is broken

store at 60-85° F

INACTIVE INGREDIENT

Inactive ingredients

Acrylates/Acrylamide Copolymer, Alpha-Lipoic Acid, Beeswax, Butylene Glycol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteraryl Alcohol, Ceteth-20, Ceteth-10 Phosphate, Denatured Alcohol, Dicetyl Phosphate, Dimethicone, Glycerin, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Isopropyl Myristate, Laureth-7, Lecithin, Mineral Oil, PEG-6 Stearate, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate 85, Purified Water, Steareth-2, Steareth-20, Steareth-21.

QUESTIONS

Questions?

1-866-335-3596 Monday to Friday 8 am to 6 pm EST .

PRINCIPAL DISPLAY PANEL

Burn Relief Label.jpg

INGREDIENTS AND APPEARANCE

BURN RELIEF 
allantoin, lidocaine, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72042-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 mg  in 100 mg
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 mg  in 100 mg
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	1.5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
CETETH-20 (UNII: I835H2IHHX)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM DICETYL PHOSPHATE (UNII: WMV3R5DS7O)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-6 STEARATE (UNII: 8LQC57C6B0)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-20 (UNII: L0Q8IK9E08)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
PEG-120 GLYCERYL STEARATE (UNII: 6941286E4I)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURETH-7 (UNII: Z95S6G8201)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE 100 (UNII: RO266O364U)
POLYSORBATE 85 (UNII: A7F3N56197)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ACRYLAMIDE (UNII: 20R035KLCI)
CETYL ALCOHOL (UNII: 936JST6JCN)
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
.ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)
STEARETH-21 (UNII: 53J3F32P58)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72042-003-03	1 in 1 CARTON	05/19/2018
1		28300 mg 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 not final	part348	05/16/2018

Labeler - HUMN Pharmaceuticals Inc (245630272)

Registrant - Delta Pharma Inc (200161730)

Establishment
Name	Address	ID/FEI	Business Operations
Delta Pharma Inc.		200161730	manufacture(72042-003)