HARMONY NEUROCOMFORT 4% LIDOCAINE PAIN RELIEF CREAM-GEL 1000MG- lidocaine cream

Harmony NeuroComfort 4% Lidocaine Pain Relief Cream-Gel 1000mg by

Drug Labeling and Warnings

Harmony NeuroComfort 4% Lidocaine Pain Relief Cream-Gel 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

Active Ingredient

Lidocaine HCl 4%

PURPOSE

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

INDICATIONS & USAGE

Uses Temporary Relief of pain

WARNINGS

For external use only

WHEN USING

When using this product, Avoid contact with eyes and mucous membranes.

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-21

Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HARMONY NEUROCOMFORT 4% LIDOCAINE PAIN RELIEF CREAM-GEL 1000MG 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-064
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-064-01	85.05 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/06/2020

Labeler - Harmony Products LLC. (117041828)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(73096-064)