LOCAL ANESTHETIC ANORECTAL CREAM- lidocaine cream

Local Anesthetic Anorectal Cream by

Drug Labeling and Warnings

Local Anesthetic Anorectal Cream by is a Otc medication manufactured, distributed, or labeled by Make Labs LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients purpose

Lidocaine 5%........Local Anesthetic

PURPOSE

Uses

Temporary relief of pain, itching, and discomfort associated with hemorrhoids

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if

• rectal bleeding occurs
• condition worsens or does not improve within 7 days
• certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

WARNINGS

Warnings

For external use only

If pregnant or breast-feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION

Directions

• Adults: When practical, clean affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Apply externally to the affected area up to 6 times a day.
• Children 12 and under, consult a physician prior to use.

INACTIVE INGREDIENT

Inactive ingredients Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butyrospermum Parkii (Shea) Butter, Benzyl Alcohol, Cetearyl Alcohol, Ceteth-20, Carbomer, Cholesterol, Ethoxydiglycol, Lecithin, PPG-12/SMDI Copolymer, Propanediol, Polysorbate 60, Simmondsia Chinensis (Jojoba) Seed Oil, Water.

PRINCIPAL DISPLAY PANEL

numbing.com

Local Anesthetic

Anorectal Cream

Net Wt. 6 OZ / 170g

INGREDIENTS AND APPEARANCE

LOCAL ANESTHETIC ANORECTAL CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84767-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
CHOLESTEROL (UNII: 97C5T2UQ7J)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
PROPANEDIOL (UNII: 5965N8W85T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
JOJOBA OIL (UNII: 724GKU717M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84767-001-01	170 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	08/01/2024

Labeler - Make Labs LLC (126167088)