Label: BURN RELIEFPREFERRED PLUS PH PREFERRED PLUS PHARMACY- lidocaine hcl gel
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Contains inactivated NDC Code(s)
NDC Code(s): 61715-022-08 - Packager: Kinray 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 March 15, 2013
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BURN RELIEFPREFERRED PLUS PH PREFERRED PLUS PHARMACY
lidocaine hcl gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-022 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS .5 g in 100 mL Inactive Ingredients Ingredient Name Strength Aloe (UNII: V5VD430YW9) Isopropyl Alcohol (UNII: ND2M416302) Propylene Glycol (UNII: 6DC9Q167V3) Glycerin (UNII: PDC6A3C0OX) Menthol (UNII: L7T10EIP3A) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) TROLAMINE (UNII: 9O3K93S3TK) Water (UNII: 059QF0KO0R) Edetate Disodium (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-022-08 237 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 03/15/2013 Labeler - Kinray Inc. (012574513)