Ubredol Methyl Salicylate 10% (wp)(da)

Ubredol Methyl Salicylate 10% (wp)(da)
SPL v3
SPL
SPL Set ID fe96eead-1722-c05d-e053-6394a90a850f
Route
TOPICAL
Published
Effective Date 2023-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g)
Inactive Ingredients
Camphor, (-)- Levomenthol D&c Yellow No. 11 Mineral Oil Paraffin Propylparaben Petrolatum Lanolin Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-06-20 Until 2026-11-01

Description

Active ingredient Purpose Methyl salicylate 10% .................. Topical analgesic


Medication Information

Description

Active ingredient Purpose Methyl salicylate 10% .................. Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Do Not
  • apply on wounds or irritated skin
  • bandage tightly
Section 55105-1
Active ingredient Purpose
Methyl salicylate 10% .................. Topical analgesic

Warnings

For external use only. Avoid contact with the eyes.

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
Distributed By:

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

Other Information
  • store between 59°- 86°F (15 - 30°C)
  • do not use if clear seal over jar is broken, torn or missing
Inactive Ingredients

camphor, D&C yellow #11, eucalyptus oil, lanolin oil, levomenthol, mineral oil, petrolatum, propylparaben, tea tree oil

Principal Display Panel

If Pregnant Or Breast Feeding,

ask a health care professional before use.

Keep Out of Reach of Children.

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

Stop Use and Ask Doctor Immediately If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Do Not (Do not)
  • apply on wounds or irritated skin
  • bandage tightly
Section 55105-1 (55105-1)
Active ingredient Purpose
Methyl salicylate 10% .................. Topical analgesic

Warnings

For external use only. Avoid contact with the eyes.

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
Distributed By: (Distributed by:)

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

Other Information (Other information)
  • store between 59°- 86°F (15 - 30°C)
  • do not use if clear seal over jar is broken, torn or missing
Inactive Ingredients (Inactive ingredients)

camphor, D&C yellow #11, eucalyptus oil, lanolin oil, levomenthol, mineral oil, petrolatum, propylparaben, tea tree oil

Principal Display Panel

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health care professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Ask Doctor Immediately If (Stop use and ask doctor immediately if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Advanced Ingredient Data


Raw Label Data

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