Label: CARPAL COMFORT- benzyl alchohol, lidocaine hci cream
- NDC Code(s): 73214-001-01
- Packager: Comfort Lab, LP
- 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 January 10, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- STOP USE
- ADDITIONAL INFORMATION
- QUESTIONS
- PURPOSE
-
INDICATIONS & USAGE
LIDOCAINE HYDROCHLORIDE
BENZYL ALCOHOL
POLYSORBATE 20
PROPYLENE GLYCOL
BOSWELLIA SERRATA RESIN OIL
ILEX PARAGUARIENSIS LEAF
MAGNESIUM SULFATE, UNSPECIFIED
SPEARMINT OIL
ALCOHOL
TRIETHANOLAMINE SULFATE
XANTHAN GUM
WATER
PHENOXYETHANOL
ARNICA MONTANA FLOWER WATER
DIMETHYL SULFONE
CARBOMER 980
ETHOXYDIGLYCOL BEHENATE
- DOSAGE & ADMINISTRATION
-
INACTIVE INGREDIENT
LIDOCAINE HYDROCHLORIDE
BENZYL ALCOHOL
POLYSORBATE 20
PROPYLENE GLYCOL
BOSWELLIA SERRATA RESIN OIL
ILEX PARAGUARIENSIS LEAF
MAGNESIUM SULFATE, UNSPECIFIED
SPEARMINT OIL
ALCOHOL
TRIETHANOLAMINE SULFATE
XANTHAN GUM
WATER
PHENOXYETHANOL
ARNICA MONTANA FLOWER WATER
DIMETHYL SULFONE
CARBOMER 980
ETHOXYDIGLYCOL BEHENATE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CARPAL COMFORT
benzyl alchohol, lidocaine hci creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73214-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL 10 mg in 100 mL LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 mg in 100 mL Inactive Ingredients Ingredient Name Strength ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) SPEARMINT OIL (UNII: C3M81465G5) ALCOHOL (UNII: 3K9958V90M) TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR) CARBOMER 940 (UNII: 4Q93RCW27E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73214-001-01 1 in 1 BOX 07/10/2019 1 88 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/10/2019 Labeler - Comfort Lab, LP (117057860)