HARMONY NEUR PAIN RELIEF- lidocaine spray

Harmony Neur Pain Relief by

Drug Labeling and Warnings

Harmony Neur Pain Relief by is a Otc medication manufactured, distributed, or labeled by Harmony Products LLC., Inspec Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Lidocaine HCl 4%

PURPOSE

Lidocaine HCl 4% .............Topical analgesic

INDICATIONS & USAGE

Uses Temporary Relief of pain and itching due to: sunburn, scrapes, insect bites, minor skin irritations.

WARNINGS

For external use only

WHEN USING

When using this product, avoid contact with eyes, use only as directed, do not puncture or incinerate, content under pressure, do not store at temperature above 120 F.

STOP USE

Stop use and ask a doctor if, condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

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 no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor.

INACTIVE INGREDIENT

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Aloe Barbadensis Leaf Extract

Aminomethyl Propanol

C30-45 Alkyl Cetearyl Dimethicone Crosspolymer

Caprylyl Methicone

Cetearyl Alcohol

Ceteth-20 Phosphate

Dicetyl Phosphate

Dimethicone

Disodium EDTA

Ethylhexylglycerin

Full Spectrum Industrial Hemp Extract

Glyceryl Stearate

Methylparaben

SD Alcohol 40

Steareth-

Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HARMONY NEUR PAIN RELIEF 
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-049
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE 100 (UNII: RO266O364U)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEMP (UNII: TD1MUT01Q7)
METHYLPARABEN (UNII: A2I8C7HI9T)
STEARETH-21 (UNII: 53J3F32P58)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-049-01	127 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/26/2019

Labeler - Harmony Products LLC. (117041828)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC		081030372	manufacture(73096-049)