FDA.reportPublic FDA data

Histamine DHCl 0_10 Percent Topical Spray

Manufacturer
7T Pharma LLC
Effective date
2018-06-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:54:09

Label at a glance#

ProductHistamine DHCl 0.10 Percent
Active ingredientHISTAMINE DIHYDROCHLORIDE
Label structure9 sections

Indications and 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.

Dosage and administration

 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

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

HISTAMINE - Histamine DHCl 0.10% topical spray
7T Pharma, LLC 

----------

Histamine DHCl 0.10% Topical Spray

​Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Histamine Dihydrochloride 0.10%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

​For external use only.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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, Isopropyl Alcohol, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol

Histamine DHCL 0.10% Topical Spray

NDC 70645-264-11

4 fl oz (118mL)

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70645-264-11
HISTAMINE
DIHYDROCHLORIDE 0.10%
topical spray
4 Fl OZ.(118 mL)

PRINCIPAL DISPLAY PANEL NDC 70645-264-11 HISTAMINE DIHYDROCHLORIDE 0.10% topical spray 4 Fl OZ.(118 mL)PRINCIPAL DISPLAY PANEL NDC 70645-264-11 HISTAMINE DIHYDROCHLORIDE 0.10% topical spray 4 Fl OZ.(118 mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70645-264-112024-03-06C16284748780-1f386c649-9f81-0266-e053-dadaa90a7c1aHistamine DHCl 0_10 Percent Topical Spray
70645-264-112023-01-30C16284748780-1f386c649-9f81-0266-e053-dadaa90a7c1aHistamine DHCl 0_10 Percent Topical Spray

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70645-264-11ML - Milliliter70645-2645e05afbb-01a3-4e92-9cbf-a7ece347764e12018-07-03

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70645-26470645-264-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CETYL MYRISTOLEATE87P8K33Q5XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
661c42bd-19c3-412c-8d6d-fd61863e1c519cd4ac32-703f-422d-8071-33db95b6d3d42024-03-11WarningsExact identifier
spl set id: 9cd4ac32-703f-422d-8071-33db95b6d3d4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.