Label: PROTEC ROLL-ON- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 68678-067-04 - Packager: ACH VENTURES 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 February 24, 2016
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings:
- When using this product: Use only as directed
- Stop use and ask doctor if:
- If Pregnant or Breast Feeding:
- Keep Out of Reach of Children
- Directions
- Other Information
- Inactive Ingredients
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROTEC ROLL-ON
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68678-067 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 8 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) 50 mL in 100 mL WATER (UNII: 059QF0KO0R) 26.99 mL in 100 mL ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) 5 mL in 100 mL DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) 3 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 3 mL in 100 mL BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ) 1 mL in 100 mL ARNICA MONTANA (UNII: O80TY208ZW) 1 mL in 100 mL (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) .40 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) .40 mL in 100 mL YUCCA SCHIDIGERA (UNII: 08A0YG3VIC) .10 mL in 100 mL PEPPERMINT OIL (UNII: AV092KU4JH) .05 mL in 100 mL EUCALYPTUS OIL (UNII: 2R04ONI662) .05 mL in 100 mL NITRIC OXIDE (UNII: 31C4KY9ESH) .001 mL in 100 mL Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68678-067-04 95 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 02/19/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/19/2016 Labeler - ACH VENTURES CORP (131871779) Establishment Name Address ID/FEI Business Operations ACH VENTURES CORP 131871779 manufacture(68678-067)
