Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 65282267-de63-453a-a686-f8752c71b9ef
Route
TOPICAL
Published
Effective Date 2014-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (10.2 g) Menthol (15.3 g) Salicylic Acid (49.1 g)
Inactive Ingredients
.beta.-carotene Chinese Cinnamon Oil D&c Green No. 6 D&c Red No. 17 Eucalyptus Oil Lavender Oil Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-03-07

Description

Active ingredients Camphor 10% Menthol 15% Methyl salicylate 48%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

Tempoarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and Administration

Directions

  • adults and children 3 years of age and older: apply on the affected area not more than 3 to 4 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage gently.
  • children under 3 years of age: do not use, consult your physician
  • refer to the above warnings; use otherwise than as directed may be dangerous
Description

Active ingredients Camphor 10% Menthol 15% Methyl salicylate 48%

Section 44425-7

Other information

  • store at 30º C (86º F) or below, away from direct sunlight.
  • keep container tightly closed
Section 50565-1

Keep out of reach of children to avoid accidental poisoning.

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

Section 50566-9

Stop use and ask a doctor if

  • condition worsens
  • symptoms persis for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive irritation develops
  • nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
  • when using for pain of arthritis:
  •      pain persists for more than 10 days
  •      redness is present
  •      in conditions affecting children under 12 years of age
Section 50567-7

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly
Section 50570-1

Do not use

  • on wounds
  • on irritated or damaged skin
  • otherwise than as directed
Section 51727-6

Inactive ingredients

Beta carotene, Cassia oil, D C Green No. 6, D C Red No. 17, Eucalyptus oil, Fragrance, Lavender oil, Mineral oil.

Section 51945-4

WHITE FLOWER STRAIN RELIEF PAIN RELIEVING OIL NDC 48256-0041-1 1.7 FL OZ (50 ML)

Section 53413-1

Questions or comments?

(888) 221-3496 M-F 9 am to 5 pm

Section 55105-1

Purpose

External Analgesic

Section 55106-9

Active ingredients

Camphor 10%

Menthol 15%

Methyl salicylate 48%


Structured Label Content

Indications and Usage (34067-9)

Uses

Tempoarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and Administration (34068-7)

Directions

  • adults and children 3 years of age and older: apply on the affected area not more than 3 to 4 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage gently.
  • children under 3 years of age: do not use, consult your physician
  • refer to the above warnings; use otherwise than as directed may be dangerous
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • store at 30º C (86º F) or below, away from direct sunlight.
  • keep container tightly closed
Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens
  • symptoms persis for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive irritation develops
  • nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
  • when using for pain of arthritis:
  •      pain persists for more than 10 days
  •      redness is present
  •      in conditions affecting children under 12 years of age
Section 50567-7 (50567-7)

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly
Section 50570-1 (50570-1)

Do not use

  • on wounds
  • on irritated or damaged skin
  • otherwise than as directed
Section 51727-6 (51727-6)

Inactive ingredients

Beta carotene, Cassia oil, D C Green No. 6, D C Red No. 17, Eucalyptus oil, Fragrance, Lavender oil, Mineral oil.

Section 51945-4 (51945-4)

WHITE FLOWER STRAIN RELIEF PAIN RELIEVING OIL NDC 48256-0041-1 1.7 FL OZ (50 ML)

Section 53413-1 (53413-1)

Questions or comments?

(888) 221-3496 M-F 9 am to 5 pm

Section 55105-1 (55105-1)

Purpose

External Analgesic

Section 55106-9 (55106-9)

Active ingredients

Camphor 10%

Menthol 15%

Methyl salicylate 48%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)