Label: SHELO NABEL HIELO MINERAL- menthol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 71424-1060-1 - 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)
- Actieve Ingredient U060
- Inactive Ingredient
- Warnings
- KROC U060
- Uses U060
- Administration
- Indications U060
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INGREDIENTS AND APPEARANCE
SHELO NABEL HIELO MINERAL
menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71424-1060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 2 mg in 1 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 12.5 mg in 1 g Inactive Ingredients Ingredient Name Strength DIMETHYL SALICYLATE (UNII: SB18J2MCQL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71424-1060-1 260 g in 1 BOTTLE, SPRAY; 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)
