MILAGROSO- methyl salicylate ointment

Milagroso by

Drug Labeling and Warnings

Milagroso by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient & Purpose

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

Uses

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

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only. Avoid contact with the eyes.

Do not

• apply on wounds or irritated skin
• bandage tightly

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

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.

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

Distributed by:

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

Principal Display Panel

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

INGREDIENTS AND APPEARANCE

MILAGROSO 
methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-378
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR, (-)- (UNII: 213N3S8275)
LEVOMENTHOL (UNII: BZ1R15MTK7)
D&C YELLOW NO. 11 (UNII: 44F3HYL954)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN OIL (UNII: OVV5IIJ58F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-378-05	142 g in 1 JAR; Type 0: Not a Combination Product	06/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/10/2023

Labeler - Pharmadel LLC (030129680)