sheffield thermarub capsaicin cream 

sheffield thermarub capsaicin cream 
SPL v3
SPL
SPL Set ID 724b9870-e86a-4087-ba78-8c944ce3baa6
Route
topical
Published
Effective Date 2023-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
sorbitol water isopropyl myristate cetyl alcohol glyceryl monostearate peg-100 stearate benzyl alcohol petrolatum paraffin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-12-22

Purpose

<Topical analgesic>

Description

Drug Facts


Medication Information

Warnings



For external use only



Avoid contact with the eyes and mucous membranes

  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin.
  • Discontinue use if excessive irritation of skin develops.
  • If pregnant or breast feeding, ask a health professional before use.
  • A temporary burning sensation may occur upon application, but generally disappears in a few days

Uses
  • For the temporary relief of  minor aches and pains of muscles and joints associated with simple backache, arthritis,strains,bruises and sprains
Purpose



<Topical analgesic>

Directions


  • Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
  • Unless treating hands, wash thoroughly with soap and water immediately after use.
Other Information
  • Store at controlled room temperature 20°- 25°C (68° - 77°F)
  • Close the cap tightly after use
Inactive Ingredients

Benzyl Alcohol, Cetyl Alcohol, Glyceryl Sterate, Isopropyl Myristate, Paraffin, PEG-100 Stearate, Petrolatum, Purified Water , Sorbitol

Description

Drug Facts

Section 42229-5

Drug Facts

Active Ingredient

Capsicum Oleoresin 0.075%

Principal Display Panel – 60g Tube Label

Sheffield Pharmaceuticals          NDC 11527-080-60

High Potency 

ARTHRITIS & MUSCLE PAIN RELIEF CREAM

0.075% Capsaicin Topical Analgesic Cream 

NET WT. 60g (2.11oz)

Principal Display Panel – 60gm Carton Label

Sheffield Pharmaceuticals                   NDC 11527-080-60

High Potency 

ARTHRITIS & MUSCLE PAIN RELIEF CREAM

0.075% Capsaicin Topical Analgesic Cream 

NET WT. 60g (2.11oz)

Keep This and All Drugs Out of the Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately


Structured Label Content

Warnings



For external use only



Avoid contact with the eyes and mucous membranes

  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin.
  • Discontinue use if excessive irritation of skin develops.
  • If pregnant or breast feeding, ask a health professional before use.
  • A temporary burning sensation may occur upon application, but generally disappears in a few days

Uses
  • For the temporary relief of  minor aches and pains of muscles and joints associated with simple backache, arthritis,strains,bruises and sprains
Purpose



<Topical analgesic>

Directions


  • Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
  • Unless treating hands, wash thoroughly with soap and water immediately after use.
Other Information
  • Store at controlled room temperature 20°- 25°C (68° - 77°F)
  • Close the cap tightly after use
Inactive Ingredients (Inactive ingredients)

Benzyl Alcohol, Cetyl Alcohol, Glyceryl Sterate, Isopropyl Myristate, Paraffin, PEG-100 Stearate, Petrolatum, Purified Water , Sorbitol

Section 42229-5 (42229-5)

Drug Facts

Active Ingredient

Capsicum Oleoresin 0.075%

Principal Display Panel – 60g Tube Label

Sheffield Pharmaceuticals          NDC 11527-080-60

High Potency 

ARTHRITIS & MUSCLE PAIN RELIEF CREAM

0.075% Capsaicin Topical Analgesic Cream 

NET WT. 60g (2.11oz)

Principal Display Panel – 60gm Carton Label

Sheffield Pharmaceuticals                   NDC 11527-080-60

High Potency 

ARTHRITIS & MUSCLE PAIN RELIEF CREAM

0.075% Capsaicin Topical Analgesic Cream 

NET WT. 60g (2.11oz)

Keep This and All Drugs Out of the Reach of Children. (Keep this and all drugs out of the reach of children.)

If swallowed, get medical help or contact a Poison Control Center immediately


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)