MILAGROSO- camphor 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
• Camphor 10 %.............................................................: Topical analgesic

Uses

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

• back aches
• arthritis
• strains
• sprains

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes .

Do not

• apply to on wounds or damaged skin
• bandage tightly

Stop use and ask a doctor if

• condition worsens or 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 professional before use.

Keep out of reach of children.

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

Directions

• adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: consult a doctor

Other information

• store in a cool dry place
• ​do not use if seal over cap is broken, torn, or missing

Inactive Ingredients

cyclomethicone 5, petrolatum

Questions or Comments?

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Dist. by:

Pharmadel LLC

Georgetown, DE 19720

Principal Display Panel

INGREDIENTS AND APPEARANCE

MILAGROSO 
camphor ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-417
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-417-02	57 g in 1 JAR; Type 0: Not a Combination Product	04/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/01/2024

Labeler - Pharmadel LLC (030129680)