Label: FRICCILICONT - menthol and methyl salicylate cream
- NDC Code(s): 53038-001-10
- Packager: Labocont Industrial
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredients
Methyl Salicylate 10%Close
For the temporary relief of minor aches and pains of muscles and joints associated with
- simple backache
For external use only. Avoid contact with the eyes.Close
- When using this product
do not apply to wounds or damaged skin
do not bandage tightlyClose
- Stop use and ask a doctor
condition worsens, or if symptoms persist for more than 7
days or clear up and occur again within a few days
redness is present
excessive irritation of the skin developsClose
- If pregnant or breast-feeding
ask a health professional before use.Close
- Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.Close
Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily.
Children under 2 years of age: Consult a physician.Close
- Inactive Ingredients
stearic acid, turpentine, waterClose
- PRINCIPAL DISPLAY PANEL
DO NOT DRINK
EFFECTIVE AND REINFORCED
Sto. Dgo., Rep. Dom.
LABORATORIOS, C. x A.
Made In Dominican Republic
Net Wt 10 oz (284 g)
MADE IN DOMINICAN REPUBLIC
MANUFACTURED FOR LABOCONT INDUSTRIAL, Km 19, Autopista las Americas, La Caleta. Sto. Dgo
DOMINICAN REPUBLIC TO REPORT A SERIOUS ADVERSE EVENT CONTACT 8109-756-7371
- INGREDIENTS AND APPEARANCE
menthol, methyl salicylate cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53038-001 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 3 g in 100 g METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 10 g in 100 g Inactive Ingredients Ingredient Name Strength STEARIC ACID TURPENTINE WATER Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53038-001-10 284 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/15/2012 Labeler - Labocont Industrial (871485509)