Ultra-strength Pain Relief Ointment

Ultra-strength Pain Relief Ointment
SPL v2
SPL
SPL Set ID 159c5a84-bf68-41dd-a2d3-bc2402037244
Route
TOPICAL
Published
Effective Date 2024-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (110 mg) Menthol, Unspecified Form
Inactive Ingredients
Chinese Cinnamon Leaf Oil Clove Oil Glyceryl Monocaprylate Glyceryl 1-undecylenate Mauritia Flexuosa Fruit Oil Peppermint Oil Petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-14

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 53414-9

If you are pregnant, or breast-feeding or if you have sensitive skin, ask a health professional before use.

Section 55105-1
Active ingredient Purpose
Camphor 11% Topical analgesic
Menthol 11% Topical analgesic
Warnings

For external use only

Directions

Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: do not use, consult a doctor.

Other Information

store in a cool dry place with the lid closed tightly.

Inactive Ingredients

Cinnamomum Cassia Leaf Oil, Eugenia Caryophyllus (Clove) Bud Oil, Glyceryl Caprylate, Glyceryl Undecylenate, Mauritia Flexuosa Fruit Oil, Melaleuca Leucadendron Cajaput Leaf Extract, Mentha Piperita (Peppermint) Oil, Petrolatum

Questions Or Comments?

1-866-567-8600

When Using This Product
  • avoid contact with the eyes and the mucous membranes
  • use only as directed
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pads or heating devices
  • do not use 1 hour before bathing or within 30 minutes after bathing
  • wash hands after use with cool water.
Stop Use and Ask A Doctor If
  • condition worsens
  • severe skin irritation occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days.
Principal Display Panel 18 G Jar Carton

Compare to active ingredients in

Tiger Balm® Ultra Strength*

Ultra-Strength

Pain Relief Ointment

Camphor 11% / Topical Analgesic

Menthol 11% / Topical Analgesic

  • Deep penetrating formula
  • Concentrated

up&up

NET WT 0.63 OZ (18 g)


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 53414-9 (53414-9)

If you are pregnant, or breast-feeding or if you have sensitive skin, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredient Purpose
Camphor 11% Topical analgesic
Menthol 11% Topical analgesic
Warnings

For external use only

Directions

Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: do not use, consult a doctor.

Other Information (Other information)

store in a cool dry place with the lid closed tightly.

Inactive Ingredients (Inactive ingredients)

Cinnamomum Cassia Leaf Oil, Eugenia Caryophyllus (Clove) Bud Oil, Glyceryl Caprylate, Glyceryl Undecylenate, Mauritia Flexuosa Fruit Oil, Melaleuca Leucadendron Cajaput Leaf Extract, Mentha Piperita (Peppermint) Oil, Petrolatum

Questions Or Comments? (Questions or comments?)

1-866-567-8600

When Using This Product (When using this product)
  • avoid contact with the eyes and the mucous membranes
  • use only as directed
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pads or heating devices
  • do not use 1 hour before bathing or within 30 minutes after bathing
  • wash hands after use with cool water.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • severe skin irritation occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days.
Principal Display Panel 18 G Jar Carton (PRINCIPAL DISPLAY PANEL - 18 g Jar Carton)

Compare to active ingredients in

Tiger Balm® Ultra Strength*

Ultra-Strength

Pain Relief Ointment

Camphor 11% / Topical Analgesic

Menthol 11% / Topical Analgesic

  • Deep penetrating formula
  • Concentrated

up&up

NET WT 0.63 OZ (18 g)


Advanced Ingredient Data


Raw Label Data

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