Label: TOPICAL ANALGESIC- dermaline 3 in 1 roll on emulsion
-
Contains inactivated NDC Code(s)
NDC Code(s): 82165-107-03 - Packager: Dermaline USA Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 April 26, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INSTRUCTIONS FOR USE
- WARNINGS
-
DO NOT USE
Do not use on wounds or damaged skin, with a bandage, with heating pad, over extensive areas of the body, on children under 16 years of age unless directed by a doctor. If pregnant or breast-feeding ask a health professional before use. In case of accidental ingestion, get medical help or contact a Poison Control center immediately.
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TOPICAL ANALGESIC
dermaline 3 in 1 roll on emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82165-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 15 g in 100 g Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) POLYSORBATE 20 (UNII: 7T1F30V5YH) TRIETHANOLAMINE MYRISTATE (UNII: 68B0CQC306) TEA TREE OIL (UNII: VIF565UC2G) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) WATER (UNII: 059QF0KO0R) DMDM HYDANTOIN (UNII: BYR0546TOW) EUCALYPTUS OIL (UNII: 2R04ONI662) CARBOMER 940 (UNII: 4Q93RCW27E) MENTHOL (UNII: L7T10EIP3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CAPSICUM OLEORESIN (UNII: UW86K581WY) ISOPROPYL ALCOHOL (UNII: ND2M416302) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82165-107-03 85.05 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 04/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/15/2022 Labeler - Dermaline USA Corp (016069241)