Carpal Comfort: Package Insert and Label Information

CARPAL COMFORT- benzyl alcohol and lidocaine hydrochloride cream
Comfort Lab, LP

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.

Benzyl Alcohol, Lidocaine HCl

INDICATIONS

For temporary relief of pain.

• For external use only
• Avoid contact with eyes

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

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

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

ADDITIONAL INFORMATION

Store at room temperature.

Questions or comments? www.carpalcomfort.com

Topical Anesthetic

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

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

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

CARPAL COMFORT benzyl alchohol, lidocaine hci cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73214-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZYL ALCOHOL (BENZYL ALCOHOL) BENZYL ALCOHOL 10 mg in 100 mL LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 mg in 100 mL

Inactive Ingredients Ingredient Name Strength ETHOXYDIGLYCOL BEHENATE DIMETHYL SULFONE 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 CARBOMER 940

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73214-001-01 1 TUBE, WITH APPLICATOR in 1 BOX contains a TUBE, WITH APPLICATOR 1 88 mL in 1 TUBE, WITH APPLICATOR This package is contained within the BOX (73214-001-01)

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)

Revised: 07/2019 Comfort Lab, LP