Label: AMINO ACTIVE TOPICAL ANALGESIC CREAM- histamine dihydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

  • Active ingredients

    Histamine DHCl 0.025%

    Purpose

    Topical Analgesic

  • Uses:

    • For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, simple back aches, strains, bruises, and sprains.
    • Provides penetrating pain relief.
  • Warnings:

    For External Use Only

    Do not

    • apply to wounds or damaged skin.
    • bandage tightly.

    When using this product

    • Avoid contact with eyes.

    Stop use and ask a doctor if

    • condition worsens, or if 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 orcontact a Poison Control Center right away.

    If pregnant or breastfeeding

    ask a health professional before use.

  • Directions:

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. 
    • Children under 2 years of age: consult a doctor.
  • Other Information:

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients:

    Alpha GEE®, Cetyl Alcohol, Colloidal Oatmeal, Dioctyl Sodium Sulfosuccinate, Glyceryl MonoStearate, Polyethylene Glycol, Polyethylene Glycol 400, Polyethylene Glycol 3350, Sodium Hydroxide.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    AMINO ACTIVE TOPICAL ANALGESIC CREAM 
    histamine dihydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82908-357
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OATMEAL (UNII: 8PI54V663Y)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82908-357-0081.33 mL in 1 JAR; Type 0: Not a Combination Product08/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/08/2022
    Labeler - VIREO SYSTEMS, INC. (832940295)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!