Label: LUROSIL- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 58697-539-02 - Packager: Pacific Health Collabroative
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated August 5, 2013
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- Official Label (Printer Friendly)
- Active ingredient
- Uses
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WARNINGS
For external use only
Do not use
- on wound s or damaged skin
- with a heating pad
- on a child under 12 years of age with arthritis-like conditions
- on wound s or damaged skin
- Directions
- Other information
- Inactive ingredients
- Package label
- Contact Us
- Purpose
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INGREDIENTS AND APPEARANCE
LUROSIL
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58697-539 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) glycerin (UNII: PDC6A3C0OX) isopropyl alcohol (UNII: ND2M416302) methylparaben (UNII: A2I8C7HI9T) polysorbate 60 (UNII: CAL22UVI4M) water (UNII: 059QF0KO0R) trolamine (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58697-539-02 1 in 1 BOX 1 57 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/17/2013 Labeler - Pacific Health Collabroative (555568133)