Label: SEA AND SKI COOLEST BURN RELIEF- lidocaine hydrochloride gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 73440-2027-1 - Packager: Cross Brands Contract Filling
- 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 February 19, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SEA AND SKI COOLEST BURN RELIEF
lidocaine hydrochloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73440-2027 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 11.9 g in 234.6 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 207.8 mL in 234.6 g Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73440-2027-1 234.6 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/04/2017 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/04/2017 Labeler - Cross Brands Contract Filling (117871824) Establishment Name Address ID/FEI Business Operations Cross Brands Contract Filling 117871824 label(73440-2027) , manufacture(73440-2027) , pack(73440-2027)
