Label: INSTAFLEX PAIN RELIEF CREAM- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70015-665-01, 70015-665-02, 70015-665-04 - Packager: Healthy Directions, LLC
- 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 June 10, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- Other information
- INACTIVE INGREDIENT
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PRINCIPAL DISPLAY PANEL
PAIN RELIEVING CREAM
Instaflex
PAIN RELIEF
Formulated with an
EXCLUSIVE OXYGENATED OIL
FAST RELIEF FOR ARTHRITIS,
JOINT & MUSCLE PAIN
POWERFUL PAIN RELIEF STARTS IN MINUTES,
LASTS FOR HOURS
Deep Penetrating | Fast Acting | Pleasant Smelling | Non-Greasy
CLINICALLY STUDIED | DOCTOR DEVELOPED
Net wt. [2/4] oz ([57/113] g)
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INGREDIENTS AND APPEARANCE
INSTAFLEX PAIN RELIEF CREAM
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70015-665 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 12.5 mg in 1 g Inactive Ingredients Ingredient Name Strength C13-14 ISOPARAFFIN (UNII: E4F12ROE70) ORANGE OIL (UNII: AKN3KSD11B) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EUCALYPTUS OIL (UNII: 2R04ONI662) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LAURETH-7 (UNII: Z95S6G8201) CORN OIL (UNII: 8470G57WFM) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494) POLYSORBATE 20 (UNII: 7T1F30V5YH) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70015-665-02 1 in 1 CARTON 01/01/2019 1 57 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70015-665-04 1 in 1 CARTON 01/01/2019 2 113 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:70015-665-01 1 in 1 CARTON 06/10/2020 3 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2019 Labeler - Healthy Directions, LLC (150261183) Establishment Name Address ID/FEI Business Operations Pure Source, LLC 080354456 manufacture(70015-665)