Amino Active Topical Analgesic Cream

Amino Active Topical Analgesic Cream
SPL v2
SPL
SPL Set ID 591b1e7e-a8c0-4640-a592-4e0f3538a40e
Route
TOPICAL
Published
Effective Date 2022-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Histamine (0.25 mg)
Inactive Ingredients
Cetyl Alcohol Oatmeal Docusate Sodium Glyceryl Monostearate Polyethylene Glycol, Unspecified Polyethylene Glycol 400 Polyethylene Glycol 3350 Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-08
Description

Histamine DHCl 0.025%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Histamine DHCl 0.025%

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.
Do Not
  • apply to wounds or damaged skin.
  • bandage tightly.
Warnings:

For External Use Only

Drug Facts

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.
Package Labeling:

Active Ingredients

Histamine DHCl 0.025%

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.

When Using This Product
  • Avoid contact with eyes.
If Pregnant Or Breastfeeding

ask a health professional before use.

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.

Structured Label Content

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.
Do Not (Do not)
  • apply to wounds or damaged skin.
  • bandage tightly.
Purpose

Topical Analgesic

Warnings:

For External Use Only

Drug Facts

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.
Package Labeling:

Active Ingredients (Active ingredients)

Histamine DHCl 0.025%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients: (Inactive ingredients:)

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

When Using This Product (When using this product)
  • Avoid contact with eyes.
If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use.

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:19.925607 · Updated: 2026-03-14T23:01:48.065872