CARPAL COMFORT- benzyl alchohol, lidocaine hci cream

Carpal Comfort by

Drug Labeling and Warnings

Carpal Comfort by is a Otc medication manufactured, distributed, or labeled by Comfort Lab, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzyl Alcohol, Lidocaine HCl

INDICATIONS

For temporary relief of pain.

WARNINGS

• For external use only
• Avoid contact with eyes

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, consult physician.

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, contact physician prior to use.

STOP USE

If symptoms persist more than seven days, discontinue use and consult physician.

ADDITIONAL INFORMATION

Store at room temperature.

QUESTIONS

Questions or comments? www.carpalcomfort.com

PURPOSE

Topical Anesthetic

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

Adults and children two-years of age and older:

Apply to affected area not more than three to four times a day.

Children under two years of age:

Consult a physician

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 cream

Product 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)