LIDOCAINE HCL 4 PERCENT AND MENTHOL 4 PERCENT- lidocaine hcl and menthol spray

Lidocaine HCl 4 Percent and Menthol 4 Percent by

Drug Labeling and Warnings

Lidocaine HCl 4 Percent and Menthol 4 Percent by is a Otc medication manufactured, distributed, or labeled by 7T Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• minor cuts
  
• sunburn
  
• minor scrapes
  
• minor burns
  
• insect bites
  
• minor skin irritations

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 older: apply externally to the affected area up to 3 to 4 times a day
• children under 2 years: ask a doctor

Other information

• May be applied under occlusive dressing.
  
• Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.

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)

INGREDIENTS AND APPEARANCE

LIDOCAINE HCL 4 PERCENT AND MENTHOL 4 PERCENT 
lidocaine hcl and menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70645-263
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70645-263-11	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	06/01/2018

Labeler - 7T Pharma LLC (080220022)