PAIN RELIEF- lidocaine, menthol cream 
HUMN Pharmaceuticals Inc

----------

Pain Relief Cream TPR 20

Active ingredients

Lidocaine Hydrochloride 4.0% (w/w)

Menthol 1.0% (w/w)

Purpose

Anesthetic

Analgesic, anesthetic, and antipruritic

Uses

Temporary relief of:

• pain

• itching associated with:

▪ minor burns ▪ sunburn ▪ minor cuts ▪ scrapes ▪ insect bites ▪ minor skin irritations

Warnings

For external use only.

Do not use

• in large quantities • over large areas of the body • 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

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, Allantoin, 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 .

TPR20 Pain Relief Label

TPR Pain Relief Label

PAIN RELIEF 
lidocaine, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72042-001
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
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)  
ALLANTOIN (UNII: 344S277G0Z)  
.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:72042-001-011 in 1 CARTON05/19/2018
170873.8 mg in 1 TUBE; Type 0: Not a Combination Product
2NDC:72042-001-031 in 1 CARTON05/19/2018
228349.5 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/19/2018
Labeler - HUMN Pharmaceuticals Inc (245630272)
Registrant - Delta Pharma Inc (200161730)
Establishment
NameAddressID/FEIBusiness Operations
Delta Pharma Inc.200161730manufacture(72042-001)

Revised: 1/2024
Document Id: 0f2c6727-1dbd-8ad5-e063-6294a90af0be
Set id: 6c96f94a-e724-eab3-e053-2991aa0aab88
Version: 2
Effective Time: 20240117
 
HUMN Pharmaceuticals Inc