Label: SERA RELIEF ULTIMATE RAPID SOOTHING CREME- lidocaine hcl cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 73385-104-60 - Packager: Sera Labs, Inc., The
- 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 October 25, 2019
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- INDICATIONS & USAGE
-
WARNINGS
Warning: For external use only
Flammable: Keep away from excessive heat or open flameWhen using this product: Avoid contact with eyes or mucous membrane. Do not apply to wounds, damaged, blistered or irritated skin. Do not use with other ointments, creams, sprays or liniments. Do not bandage. Wash hands after use with cool water. Do not use with heating pad or device.
Ask a doctor before use if you have sensitive skin. Stop use if condition worsens or persists for more than 7 days.
If pregnant or breast feeding: ask doctor before using
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Inactive Ingredients: Allantoin, Caprylic/Capric Triglyceride, Capsicum Annuum Fruit powder, Calcium Disodium EDTA, Cannabis Sativa (Aerial) Extract Oil, DL-Alpha Tocopheryl Acetate, Ethyl Alcohol, Ethylhexylglycerin, Ethylhexyl Stearate, Glycerin, Phenoxyethanol, Polysorbate 80, Propanediol, Propylene Glycol, Purified Water, Simethicone, Sodium Polyacrylate, Trideceth-6, Vitis Vinifera (Grape) seed Oil, Xanthan Gum, Beta – Caryophyllene
- SPL UNCLASSIFIED SECTION
- Packaging
-
INGREDIENTS AND APPEARANCE
SERA RELIEF ULTIMATE RAPID SOOTHING CREME
lidocaine hcl creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73385-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PAPRIKA (UNII: X72Z47861V) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP (UNII: 8X454SZ22D) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) ALCOHOL (UNII: 3K9958V90M) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPANEDIOL (UNII: 5965N8W85T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TRIDECETH-6 (UNII: 3T5PCR2H0C) GRAPE SEED OIL (UNII: 930MLC8XGG) XANTHAN GUM (UNII: TTV12P4NEE) CARYOPHYLLENE (UNII: BHW853AU9H) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73385-104-60 73 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/04/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/04/2019 Labeler - Sera Labs, Inc., The (116914405)
