MILAGROSO- methyl salicylate ointment 
Pharmadel LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Milagroso Methyl Salicylate 10% (WP)

Drug Facts

Active ingredient & Purpose

Active ingredientPurpose
Methyl salicylate 10% ..................External analgesic

Uses

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

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

Other information

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.**

Milagroso PDP

MILAGROSO 
methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-378
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-378-05142 g in 1 JAR; Type 0: Not a Combination Product06/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/10/2023
Labeler - Pharmadel LLC (030129680)

Revised: 8/2023
Document Id: 025d76f2-ab64-c811-e063-6394a90ae161
Set id: fdcc8f44-afa0-3af0-e053-6394a90aa46d
Version: 3
Effective Time: 20230807
 
Pharmadel LLC