milagroso methyl salicylate 10% (wp)(da)

milagroso methyl salicylate 10% (wp)(da)
SPL v5
SPL
SPL Set ID fdcc8f44-afa0-3af0-e053-6394a90aa46d
Route
topical
Published
Effective Date 2023-06-10
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 paraffin propylparaben petrolatum lanolin oil

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2023-06-10 Until 2027-08-01
Description

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

Medication Information

Warnings

For external use only. Avoid contact with the eyes.

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
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 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, lanolin oil, levomenthol, mineral oil, paraffin, petrolatum, propylparaben

Description

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

Principal Display Panel

**Milagroso® does not contain bee venom or snake oil but contains an active ingredient that is used as an effective analgesic.**

Do Not
  • apply on wounds or irritated skin
  • bandage tightly
Section 55105-1
Active ingredient Purpose
Methyl salicylate 10% .................. External analgesic

Distributed By:

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

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

Warnings

For external use only. Avoid contact with the eyes.

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
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 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, lanolin oil, levomenthol, mineral oil, paraffin, petrolatum, propylparaben

Principal Display Panel

**Milagroso® does not contain bee venom or snake oil but contains an active ingredient that is used as an effective analgesic.**

Do Not (Do not)
  • apply on wounds or irritated skin
  • bandage tightly
Section 55105-1 (55105-1)
Active ingredient Purpose
Methyl salicylate 10% .................. External analgesic

Distributed By: (Distributed by:)

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:29.114202 · Updated: 2026-03-14T23:11:00.469021