Label: SHELO NABEL POMADA ARNICA- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71424-1059-1 - Packager: Corporativo Serysi S de R L de C V
- 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 October 15, 2019
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- Official Label (Printer Friendly)
- Active Ingredient U059
- Inactive Ingredient U059
- Warnings U059
- Uses U059
- KROC U059
- Administration U059
- Indications U059
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INGREDIENTS AND APPEARANCE
SHELO NABEL POMADA ARNICA
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71424-1059 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 20 mg in 1 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 30 mg in 1 g Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71424-1059-1 140 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 05/18/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/18/2017 Labeler - Corporativo Serysi S de R L de C V (816628390) Registrant - Corporativo Serysi S de R L de C V (816628390)