76986-023 Gembooxt Topical Numbing Cream

76986-023 Gembooxt Topical Numbing Cream
SPL v1
SPL
SPL Set ID 49951a3e-3b62-3d66-e063-6294a90a9360
Route
RECTAL
Published
Effective Date 2026-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Trideceth-10 Dimethicone Phenoxyethanol Sodium Polyacryloyldimethyl Taurate Potassium Lauryl Phosphate Stearic Acid Glycerin Xanthan Gum Stearyl Alcohol Ceteareth-25 Glyceryl Stearate Dibasic Potassium Phosphate Triethanolamine Arnica Montana Flower Hydrogenated Polydecene (1500 Cst) Benzoic Acid Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Eucalyptus Globulus Oil Cetyl Alcohol Mineral Oil Water Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-30

Description

LIDOCAINE HCL 5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage



For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders.

For the temporary relief of pain,bumning and soreness

Dosage and Administration



For adults and children 12 years and older:

When practical, clean the area with mild soap and warm water and rinse thoroughly Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.

Apply up to 6 times daily.

Children under 12 years. Ask a doctor.

Description

LIDOCAINE HCL 5%

Section 50565-1

Keep out of reach of children. lf swallowed get medical help or contact a Poison Gontrol Center right away

Section 50566-9



Stop use and ask a doctor if

An allergic reaction is observed Symptoms such as redness, irritation,swelling, pain, orothers begin or worsen.

Does not show improvement within 7 days If pregnant or breast-feeding, ask a doctor before use.

Section 50567-7



When using this product:

Use only as much as recommended,unless a doctor advises otherwise.

Do not insert into the rectum with fingers or any mechanical device or applicator.

Section 50570-1

Do not use on broken or irritated skin.

Section 51727-6



WATER

CETYL ALCOHOL

STEARYL ALCOHOL

GLYCERIN

MINERAL OIL

SODIUM POLYACRYLOYLDIMETHYL TAURATE

HYDROGENATED POLYDECENE

TRIDECETH-10

CETEARETH-25

STEARIC ACID

GLYCERYL STEARATE

DIMETHICONE

BENZYL ALCOHOL

PHENOXYETHANOL

BENZOIC ACID

ARNICA MONTANA FLOWER EXTRACT

TRIETHANOLAMINE

EUCALYPTUS GLOBULUS LEAF OIL

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

XANTHAN GUM

POTASSIUM LAURYL PHOSPHATE

DIPOTASSIUM PHOSPHATE

Section 51945-4

Section 55105-1

Local Anesthetic

Section 55106-9

LIDOCAINE HCL 5%


Structured Label Content

Indications and Usage (34067-9)



For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders.

For the temporary relief of pain,bumning and soreness

Dosage and Administration (34068-7)



For adults and children 12 years and older:

When practical, clean the area with mild soap and warm water and rinse thoroughly Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.

Apply up to 6 times daily.

Children under 12 years. Ask a doctor.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. lf swallowed get medical help or contact a Poison Gontrol Center right away

Section 50566-9 (50566-9)



Stop use and ask a doctor if

An allergic reaction is observed Symptoms such as redness, irritation,swelling, pain, orothers begin or worsen.

Does not show improvement within 7 days If pregnant or breast-feeding, ask a doctor before use.

Section 50567-7 (50567-7)



When using this product:

Use only as much as recommended,unless a doctor advises otherwise.

Do not insert into the rectum with fingers or any mechanical device or applicator.

Section 50570-1 (50570-1)

Do not use on broken or irritated skin.

Section 51727-6 (51727-6)



WATER

CETYL ALCOHOL

STEARYL ALCOHOL

GLYCERIN

MINERAL OIL

SODIUM POLYACRYLOYLDIMETHYL TAURATE

HYDROGENATED POLYDECENE

TRIDECETH-10

CETEARETH-25

STEARIC ACID

GLYCERYL STEARATE

DIMETHICONE

BENZYL ALCOHOL

PHENOXYETHANOL

BENZOIC ACID

ARNICA MONTANA FLOWER EXTRACT

TRIETHANOLAMINE

EUCALYPTUS GLOBULUS LEAF OIL

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

XANTHAN GUM

POTASSIUM LAURYL PHOSPHATE

DIPOTASSIUM PHOSPHATE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Local Anesthetic

Section 55106-9 (55106-9)

LIDOCAINE HCL 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)