Milagroso Camphor (wp)(da)

Milagroso Camphor (wp)(da)
SPL v4
SPL
SPL Set ID 12b0401c-84d5-07cd-e063-6394a90a052c
Route
TOPICAL
Published
Effective Date 2024-03-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (10 g)
Inactive Ingredients
Petrolatum Cyclomethicone 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-04-01 Until 2026-09-01

Description

Active ingredient Purpose Camphor 10 %............................................................. Topical analgesic


Medication Information

Description

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

Do Not
  • apply to on wounds or damaged skin
  • bandage tightly
Section 55105-1
Active ingredient Purpose

Camphor 10 %.............................................................

Topical analgesic
Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes .

Dist. By:

Pharmadel LLC

Georgetown, DE 19720

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
Drug Facts

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

Principal Display Panel

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.


Structured Label Content

Uses

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

  • back aches
  • arthritis
  • strains
  • sprains

Do Not (Do not)
  • apply to on wounds or damaged skin
  • bandage tightly
Section 55105-1 (55105-1)
Active ingredient Purpose

Camphor 10 %.............................................................

Topical analgesic
Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes .

Dist. By: (Dist. by:)

Pharmadel LLC

Georgetown, DE 19720

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
Drug Facts

Other Information (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? (Questions or Comments?)

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

Principal Display Panel

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health 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 right away.


Advanced Ingredient Data


Raw Label Data

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