AMINO ACTIVE TOPICAL ANALGESIC CREAM- histamine dihydrochloride cream

AMINO ACTIVE Topical Analgesic Cream by

Drug Labeling and Warnings

AMINO ACTIVE Topical Analgesic Cream by is a Otc medication manufactured, distributed, or labeled by VIREO SYSTEMS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

AMINO ACTIVE TOPICAL ANALGESIC CREAM 
histamine dihydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82908-357
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82908-357-00	81.33 mL in 1 JAR; Type 0: Not a Combination Product	08/08/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/08/2022

Labeler - VIREO SYSTEMS, INC. (832940295)