geri-care analgesic balm

geri-care analgesic balm
SPL v2
SPL
SPL Set ID ab9bf09d-bc8c-6d17-e053-2995a90a6c36
Route
topical
Published
Effective Date 2020-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (10 g) salicylic acid (15 g)
Inactive Ingredients
polysorbate 80 trolamine carbomer 940 cetyl alcohol glyceryl monostearate methylparaben water stearic acid glycerin propylparaben

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-08-05

Description

Menthol 10%


Medication Information

Warnings

For external use only

Do not use:

  • On wounds or damaged, broken or irritated skin
  • On a child under 12 years of age with arthritis-like conditions
  • With a heating pad

Ask a doctor before use if you have redness over the affected area.

When using this product

  • Avoid contact with eyes or mucous membrane
  • Do not bandage tightly
Indications and Usage

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

Directions
  • Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.

Children under 12 years of age. consult a doctor

  • Unless treating hands, wash hands thoroughly with soap and water immediately after use.
Other Information
  • Store at controlled room temperature 20º-25ºC (68º-77ºF)

Questions ? Call 1-800-540-3765

Inactive Ingredients

Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

Description

Menthol 10%

Section 55105-1

Topical Analgesic

Packaging

Distributed By

GeriCare Pharmaceuticals

1650 63rd Street

Brooklyn, NY 11204

Product of China

Active Ingredient

Menthol 10%

Stop Use and Ask A Doctor
  • Conditions worsens or does not improve within 7 days
  • Symptoms clear up and occur again within a few days
  • Excessive skin irritation develops

Keep 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

Do not use:

  • On wounds or damaged, broken or irritated skin
  • On a child under 12 years of age with arthritis-like conditions
  • With a heating pad

Ask a doctor before use if you have redness over the affected area.

When using this product

  • Avoid contact with eyes or mucous membrane
  • Do not bandage tightly
Indications and Usage (34067-9)

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

Directions
  • Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.

Children under 12 years of age. consult a doctor

  • Unless treating hands, wash hands thoroughly with soap and water immediately after use.
Other Information
  • Store at controlled room temperature 20º-25ºC (68º-77ºF)

Questions ? Call 1-800-540-3765

Inactive Ingredients

Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

Section 55105-1 (55105-1)

Topical Analgesic

Packaging

Distributed By

GeriCare Pharmaceuticals

1650 63rd Street

Brooklyn, NY 11204

Product of China

Active Ingredient

Menthol 10%

Stop Use and Ask A Doctor (Stop Use and ask a doctor)
  • Conditions worsens or does not improve within 7 days
  • Symptoms clear up and occur again within a few days
  • Excessive skin irritation develops

Keep Out of the Reach of Children (Keep 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)