Harmony Neuro 4% Lidocaine Pain Relief

Harmony Neuro 4% Lidocaine Pain Relief

Drug Labeling and Warnings

Drug Details

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HARMONY PRODUCTS LLC.- lidocaine cream 
Harmony Products LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Harmony Neuro 4% Lidocaine Pain Relief

Active Ingredient

Lidocaine HCl 4%

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

Uses Temporary Relief of pain

For external use only

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

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

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

1000mg Neuro Roll-On

HARMONY PRODUCTS LLC. 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73096-046
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE100 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73096-046-0170.8 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2019
2NDC: 73096-046-0285.05 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/25/2019
Labeler - Harmony Products LLC. (117041828)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC.081030372manufacture(73096-046)

Revised: 10/2019
 
Harmony Products LLC.


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