PAIN RELIEF- lidocaine, menthol cream

Pain Relief by

Drug Labeling and Warnings

Pain 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

Lidocaine Hydrochloride 4.0% (w/w)

Menthol 1.0% (w/w)

PURPOSE

Purpose

Anesthetic

Analgesic, anesthetic, and antipruritic

INDICATIONS & USAGE

Uses

Temporary relief of:

pain

itching associated with:

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

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use

in large quantities over large areas of the body 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

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, 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

Questions?

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

PRINCIPAL DISPLAY PANEL

TPR20 Pain Relief Label

INGREDIENTS AND APPEARANCE

PAIN RELIEF 
lidocaine, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72042-001
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

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)
ALLANTOIN (UNII: 344S277G0Z)
.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: 72042-001-01	1 in 1 CARTON	05/19/2018
1		70873.8 mg in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 72042-001-03	1 in 1 CARTON	05/19/2018
2		28349.5 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	05/19/2018

Labeler - HUMN Pharmaceuticals Inc (245630272)

Registrant - Delta Pharma Inc (200161730)

Establishment
Name	Address	ID/FEI	Business Operations
Delta Pharma Inc.		200161730	manufacture(72042-001)