BURN RELIEF- allantoin, lidocaine, menthol cream 
HUMN Pharmaceuticals Inc

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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Burn Relief Cream

Active ingredients

Allantoin 1.5% (w/w)

Lidocaine Hydrochloride 4.0% (w/w)

Menthol 1.0% (w/w)

Purpose

Skin protectant

Anesthetic

Analgesic, anesthetic, and antipruritic

Uses

Temporary relief of pain associated with:

▪ minor burns ▪ minor skin irritations

Temporary protection of minor skin irritations

Warnings

For external use only.

Do not use

in large quantities, particularly:

• over raw surfaces • over blistered areas

Ask a doctor before use

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

When using this product

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

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. If swallowed, get

medical help or contact a Poison Control Center right away.

Directions

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

Other information

• do not use if seal is broken

• store at 60-85° F

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?

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

Burn Relief Label.jpg

Burn Relief Label

BURN RELIEF 
allantoin, lidocaine, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72042-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 100 mg
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 mg  in 100 mg
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1.5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72042-003-031 in 1 CARTON05/19/2018
128300 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/16/2018
Labeler - HUMN Pharmaceuticals Inc (245630272)
Registrant - Delta Pharma Inc (200161730)
Establishment
NameAddressID/FEIBusiness Operations
Delta Pharma Inc.200161730manufacture(72042-003)

Revised: 5/2018
Document Id: 6c948545-cd5c-5371-e053-2a91aa0a7cc1
Set id: 6c948545-cd5a-5371-e053-2a91aa0a7cc1
Version: 1
Effective Time: 20180519
 
HUMN Pharmaceuticals Inc