Medication Guide App

SoCalm External Analgesic

Dosage form: patch
Ingredients: METHYL SALICYLATE 10mg in 100mg
Labeler: AB7 Industries
NDC Code: 52815-001

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.

Drug Facts

Active Ingredient
Methyl Salicylate 10%

Purpose
External Analgesic

Use 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 getting into the eyes or on mucous membranes

When using this product 
  • do not apply to wounds or damaged skin 
  • do not bandage tightly
  • do not use otherwise than as directed

Stop use and ask a doctor if
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days 
  • pain persists for more than 10 days 
  • Redness is present 
  • conditions affect children under 12 years of age

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

Directions 
  • Open pouch and remove
  • Pull woven wrap containing external analgesic patches over knee, positioning on either side of affected area
  • 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 at 20 to 25C (68 to 77F), away from direct sunlight

Inactive Ingredients citronella oil, clove oil, coriander seed oil, macadamia nut oil, mandarin oil, polyether block amide and rosemary oil

Package Label

SOCALM  EXTERNAL ANALGESIC
methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52815-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE10 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
CITRONELLA OIL 
CLOVE OIL 
CORIANDER OIL 
MACADAMIA OIL 
MANDARIN OIL 
ROSEMARY OIL 
Packaging
#Item CodePackage Description
1NDC:52815-001-1010 mg in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/31/2010
Labeler - AB7 Industries (381206077)
Establishment
NameAddressID/FEIOperations
AB7 Industries381206077manufacture

Revised: 12/2010
 
AB7 Industries

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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