Balsamo De Vaca Mascura

Balsamo De Vaca Mascura
SPL v3
SPL
SPL Set ID 321b6f1f-c802-4b96-99d3-e77217da11a3
Route
TOPICAL
Published
Effective Date 2021-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10.5 g)
Inactive Ingredients
Camphor (synthetic) D&c Yellow No. 10 Menthol Methylparaben Paraffin Petrolatum Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-05-10

Description

Active Ingredient Purpose Methyl Salicylate 10.5 % ............................................External Analgesic


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains

Description

Active Ingredient Purpose Methyl Salicylate 10.5 % ............................................External Analgesic

Section 51945-4

Section 55105-1

Purpose

External Analgesic

Section 55106-9

Active Ingredient Purpose

Methyl Salicylate 10.5 % ............................................External Analgesic

Do Not Use
  • on wounds or damage skin
  • with a heating pad
  • on a child under 12 years of age 
  • over extensive areas of the body
  • on irritated skin
  • woth a bandage
Questions?

call 1-800-60-5223 M-F 9 AM to 4 PM Eastern

Directions 
  • Use only as directed 
  • adults and children 12 years and older apply to affected area not more tha 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other Information
  • store at 15° to 25° C (59° to 77° F)
Inactive Ingredients:

Camphor, D&C yellow 10#, menthol, methylparaben, paraffin wax, propylparaben, white petrolatum.

When Using This Product 
  • avoid contact with eyes or mucous membranes
  • do not bandage
If Pregnant Or Breast Feeding

ask a health professional before use 

Stop Use and Ask A Doctor If 
  • condition worsens or symptoms persist for more than 7 days 
  • symptoms clear up and occur again within a few days 
  • excessive skin irritation occurs
Ask Doctor Before Use If You Have 

redness over the affected area 

Keep Out of Reach of Children to Avoid Accidental Poisoning.

If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away.


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

External Analgesic

Section 55106-9 (55106-9)

Active Ingredient Purpose

Methyl Salicylate 10.5 % ............................................External Analgesic

Do Not Use (Do not use)
  • on wounds or damage skin
  • with a heating pad
  • on a child under 12 years of age 
  • over extensive areas of the body
  • on irritated skin
  • woth a bandage
Questions?

call 1-800-60-5223 M-F 9 AM to 4 PM Eastern

Directions 
  • Use only as directed 
  • adults and children 12 years and older apply to affected area not more tha 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other Information (Other information)
  • store at 15° to 25° C (59° to 77° F)
Inactive Ingredients:

Camphor, D&C yellow 10#, menthol, methylparaben, paraffin wax, propylparaben, white petrolatum.

When Using This Product  (When using this product )
  • avoid contact with eyes or mucous membranes
  • do not bandage
If Pregnant Or Breast Feeding (if pregnant or breast-feeding)

ask a health professional before use 

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )
  • condition worsens or symptoms persist for more than 7 days 
  • symptoms clear up and occur again within a few days 
  • excessive skin irritation occurs
Ask Doctor Before Use If You Have  (Ask doctor before use if you have )

redness over the affected area 

Keep Out of Reach of Children to Avoid Accidental Poisoning. (keep out of reach of children to avoid accidental poisoning.)

If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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