LIDOCAINE HCL 4 PERCENT AND MENTHOL 4 PERCENT- lidocaine hcl and menthol spray 
7T Pharma 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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Lidocaine and Menthol Topical Spray

LIDOCAINE AND MENTHOL - Lidocaine HCl 4% and Menthol 4% topical spray
7T Pharma, LLC 

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Lidocaine 4% and Menthol 4% Topical Spray

​Drug Facts

Active ingredient

Lidocaine HCl 4%

Menthol 4%

Purpose

Topical anesthetic
Topical analgesic

Uses

Temporarily relieves pain and itching due to:

Warnings

​For external use only.

When using this product

  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

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 and olderapply externally to the affected area up to 3 to 4 times a day
 children under 2 years ask a doctor

Other information

Inactive ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Myristoleate, Ethylhexylglycerin, Glycyrrhiza Glabra (Licorice) Extract, Ilex Paraguaiensis (Yerba Mate) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B

Lidocaine 4% and Menthol 4% Topical Spray

NDC 70645-263-11

4 fl oz (118mL)

Manufactured for:
7T Pharma, LLC
Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

NDC 70645-263-11
LIDOCAINE 4%
AND
MENTHOL 4%
topical spray
4 Fl oz. (118 mL)

PRINCIPAL DISPLAY PANEL
NDC 70645-263-11
LIDOCAINE 4%
AND 
MENTHOL 4%
topical spray
4 Fl oz. (118 mL)

LIDOCAINE HCL 4 PERCENT AND MENTHOL 4 PERCENT 
lidocaine hcl and menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70645-263
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70645-263-11118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34806/01/2018
Labeler - 7T Pharma LLC (080220022)

Revised: 6/2018
Document Id: 0a28fab2-c559-4dd8-842c-d91536d93080
Set id: d605fd20-e97e-40ee-9cee-fbc109c84000
Version: 2
Effective Time: 20180627
 
7T Pharma LLC