AMINO ACTIVE TOPICAL ANALGESIC CREAM- histamine dihydrochloride cream 
VIREO SYSTEMS, INC.

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AMINO ACTIVE Topical Analgesic Cream

Drug Facts

Active ingredients

Histamine DHCl 0.025%

Purpose

Topical Analgesic

Uses:

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:

Other Information:

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

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)

Revised: 11/2023
Document Id: 09e37389-88cf-6f4c-e063-6394a90a9861
Set id: 591b1e7e-a8c0-4640-a592-4e0f3538a40e
Version: 2
Effective Time: 20231111
 
VIREO SYSTEMS, INC.