CARPAL COMFORT- benzyl alchohol, lidocaine hci 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.

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Carpal Comfort

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

Bottle Box

CARPAL COMFORT
benzyl alchohol, lidocaine hci cream

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/10/2019

Labeler - Comfort Lab, LP (117057860)

Revised: 1/2023

Document Id: f1e96716-1fa1-51b5-e053-2a95a90a774d

Set id: 8d557931-0e2b-29ce-e053-2995a90adf2e

Version: 2

Effective Time: 20230110

Comfort Lab, LP