HISTAMINE DHCL 0.10 PERCENT AND MENTHOL 2 PERCENT- histamine dihydrochloride and menthol spray 
7T Pharma LLC

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Histamine DHCl and Menthol Topical Spray

HISTAMINE AND MENTHOL - Histamine DHCl 0.10% and Menthol 2% topical spray
7T Pharma, LLC

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Histamine DHCl 0.10% and Menthol 2% Topical Spray

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Drug Facts

Active ingredient

Histamine Dihydrochloride 0.10%

Menthol 2%

Purpose

Topical analgesic
Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

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

  • 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), Polysorbate-20, SD-Alcohol 40B, Phenoxyethanol

Histamine DHCl 0.10% and Menthol 2% Topical Spray

NDC 70645-265-11

4 fl oz (118mL)

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

PRINCIPAL DISPLAY PANEL

NDC 70645-265-11
Histamine Dihydrochloride 0.1%
and Menthol 2%
Topical Spray
4 Fl OZ. (118 mL)

PRINCIPAL DISPLAY PANEL NDC 70645-265-11 Histamine Dihydrochloride 0.1% and Menthol 2% Topical Spray 4 Fl OZ. (118 mL)

HISTAMINE DHCL 0.10 PERCENT AND MENTHOL 2 PERCENT 
histamine dihydrochloride and menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70645-265
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.1 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 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)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70645-265-11118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/201803/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/01/201803/01/2024
Labeler - 7T Pharma LLC (080220022)

Revised: 3/2024
Document Id: cf2ee6e2-3c5b-46d4-a93f-14f2eb150048
Set id: a8a878a2-92be-484d-99ff-4079c3310264
Version: 3
Effective Time: 20240311
 
7T Pharma LLC