Carpal Comfort

Carpal Comfort
SPL v2
SPL
SPL Set ID 8d557931-0e2b-29ce-e053-2995a90adf2e
Route
TOPICAL
Published
Effective Date 2019-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzyl Alcohol (10 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-07-10

Description

Benzyl Alcohol, Lidocaine HCl


Medication Information

Warnings and Precautions
  • For external use only
  • Avoid contact with eyes
Indications and 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 and 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

Description

Benzyl Alcohol, Lidocaine HCl

Section 50565-1

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

Section 50566-9

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

Section 51727-6

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

Section 51945-4

Section 53413-1

Questions or comments? www.carpalcomfort.com

Section 53414-9

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

Section 55105-1

Topical Anesthetic

Section 55106-9

Benzyl Alcohol, Lidocaine HCl

Indications

For temporary relief of pain.

Additional Information

Store at room temperature.


Structured Label Content

Indications and Usage (34067-9)

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 and Administration (34068-7)

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

Warnings and Precautions (34071-1)
  • For external use only
  • Avoid contact with eyes
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? www.carpalcomfort.com

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Topical Anesthetic

Section 55106-9 (55106-9)

Benzyl Alcohol, Lidocaine HCl

Indications (INDICATIONS)

For temporary relief of pain.

Additional Information (ADDITIONAL INFORMATION)

Store at room temperature.


Advanced Ingredient Data


Raw Label Data

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