Label: DENDRACIN NEURODENDRAXCIN- methyl salicylate, menthol and capsaicin lotion lotion
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- NDC Code(s): 61919-680-02, 61919-680-04
- Packager: DirectRx
- This is a repackaged label.
- Source NDC Code(s): 27495-014
- 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 September 30, 2021
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STOP USE
- DO NOT USE
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INACTIVE INGREDIENT
water, benzocaine, glyceryl stearate, PEG 100 stearate, stearic acid, cetyl alcohol, propylene glycol, dimethyl sulfoxide, triethanolamine, poloxamer 407, aloe barbadensis gel, borage oil, ammonium acryloyldimethyltaurate, zingiber officinale root extract, methylparaben, propylparaben, soya lecithin, DMDM hydantoin sodium stearoyl glutamate.
- SPL UNCLASSIFIED SECTION
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DOSAGE & ADMINISTRATION
Use only as directed. Shake before each use. Prior to first use, rub small amount to check for sensitivity. Gently rub over painful areas. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Do not use more than 4 times daily or if pregnant or nursing. If swallowed, call poison control. If placed into eyes, rinse with cold water and call a doctor.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DENDRACIN NEURODENDRAXCIN
methyl salicylate, menthol and capsaicin lotion lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61919-680(NDC:27495-014) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 18 g in 60 mL CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.015 g in 60 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 6 g in 60 mL Inactive Ingredients Ingredient Name Strength DIMETHYL SULFOXIDE (UNII: YOW8V9698H) ALOE VERA LEAF (UNII: ZY81Z83H0X) AMMONIO METHACRYLATE COPOLYMER TYPE A (UNII: 8GQS4E66YY) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) GINGER (UNII: C5529G5JPQ) METHYLPARABEN (UNII: A2I8C7HI9T) DMDM HYDANTOIN (UNII: BYR0546TOW) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) BORAGE SEED OIL (UNII: F8XAG1755S) POLOXAMER 407 (UNII: TUF2IVW3M2) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) BENZOCAINE (UNII: U3RSY48JW5) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARIC ACID (UNII: 4ELV7Z65AP) PEG-100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETYL ALCOHOL (UNII: 936JST6JCN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-680-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/14/2021 2 NDC:61919-680-04 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/14/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/14/2021 Labeler - DirectRx (079254320) Registrant - DirectRx (079254320) Establishment Name Address ID/FEI Business Operations DirectRx 079254320 relabel(61919-680)
