Label: REACTICE REACTIVATING ICE BAUME- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 75963-125-01, 75963-125-02 - Packager: Rejuventus, Inc.
- 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 January 27, 2012
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ACTIVE INGREDIENT
Active ingredients Purpose
Menthol (5%) External Analgesic
Uses
For temporary relief of minor aches and pains of muscles such as: simple backache, lumbago, arthritis, neuralgia, strains, bruises, strains, bruises, and sprains
For External use only. When using this product avoid contact with eyes. Wash hands completely after each use. If swallowed seek medical assistance immediately or contact poison control. If you are pregnant or nursing,seek the advice of your doctor before using this product.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REACTICE REACTIVATING ICE BAUME
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75963-125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 118.29 mL in 100 mL Inactive Ingredients Ingredient Name Strength DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) CLOVE (UNII: K48IKT5321) PEPPERMINT OIL (UNII: AV092KU4JH) EUCALYPTUS OIL (UNII: 2R04ONI662) ALOE VERA LEAF (UNII: ZY81Z83H0X) ASCORBIC ACID (UNII: PQ6CK8PD0R) TOCOPHEROL (UNII: R0ZB2556P8) GLYCINE (UNII: TE7660XO1C) JOJOBA OIL (UNII: 724GKU717M) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75963-125-01 118.29 mL in 1 JAR 2 NDC:75963-125-02 473 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/21/2011 Labeler - Rejuventus, Inc. (032186703) Registrant - Rejuventus, Inc. (032186703) Establishment Name Address ID/FEI Business Operations Rwm Technologies 003215779 manufacture