Label: HEMPORRHOID- lidocaine hcl cream
- NDC Code(s): 76348-590-01, 76348-590-02
- Packager: Renu Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 14, 2022
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- Official Label (Printer Friendly)
- STATEMENT OF IDENTITY
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions:
- OTHER SAFETY INFORMATION
- QUESTIONS
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INACTIVE INGREDIENT
INGREDIENTS: Capryl Glycol, Caprylic / Capric Triglyceride, Cetearyl Alcohol, Deionized Water, Emulsifying Wax NF, Ethylhexylglycerin, Glycerin, Hemp Extract with proprietary Terpene blend: (Beta Caryophyllene, Humulene, Limonene, Myrcene, Linalool, Nerolidol, Beta Pinene, Alpha Pinene, Eucalyptol), Hexylene Glycol, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Tetrasodium EDTA, Tocopherol.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEMPORRHOID
lidocaine hcl creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-590 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 1.4 g in 28 g Inactive Ingredients Ingredient Name Strength CARYOPHYLLENE (UNII: BHW853AU9H) .BETA.-PINENE (UNII: 4MS8VHZ1HJ) STEARIC ACID (UNII: 4ELV7Z65AP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WHITE WAX (UNII: 7G1J5DA97F) HUMULENE (UNII: 54W56MD2WD) MYRCENE (UNII: 3M39CZS25B) LINALOOL, (+)- (UNII: F4VNO44C09) EDETATE SODIUM (UNII: MP1J8420LU) CANNABIDIOL (UNII: 19GBJ60SN5) EUCALYPTOL (UNII: RV6J6604TK) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) HEXYLENE GLYCOL (UNII: KEH0A3F75J) .ALPHA.-PINENE (UNII: JPF3YI7O34) NEROLIDOL (UNII: QR6IP857S6) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) TOCOPHEROL (UNII: R0ZB2556P8) LIMONENE, (+)- (UNII: GFD7C86Q1W) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) JOJOBA OIL (UNII: 724GKU717M) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 20 (UNII: 7T1F30V5YH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-590-02 1 in 1 BOX 11/23/2020 1 NDC:76348-590-01 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 final part346 11/23/2020 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-590)