HARMONY HEMP NEUROCOMFORT 4% LIDOCAINE PAIN RELIEF 1000MG- lidocaine spray

Harmony Hemp NeuroComfort 4% Lidocaine Pain Relief 1000mg by

Drug Labeling and Warnings

Harmony Hemp NeuroComfort 4% Lidocaine Pain Relief 1000mg 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

Lidocaine 4%

PURPOSE

Lidocaine ................... 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

Flammable keep away from fire or flame

DO not use in large quantities over raw surfaces and blistered area

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:

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HARMONY HEMP NEUROCOMFORT 4% LIDOCAINE PAIN RELIEF 1000MG 
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-052
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
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
ALCOHOL (UNII: 3K9958V90M)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIMETHICONE 100 (UNII: RO266O364U)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
WATER (UNII: 059QF0KO0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HEMP (UNII: TD1MUT01Q7)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
STEARETH-21 (UNII: 53J3F32P58)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-052-01	127 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/29/2020

Labeler - Harmony Products LLC. (117041828)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(73096-052)