NUMB- lidocaine 5% cream

NUMB by

Drug Labeling and Warnings

NUMB by is a Otc medication manufactured, distributed, or labeled by Gabar Health Sciences Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 5% W/W

Purpose

Local Anesthetic

Uses

For the temporary roliot of local and anorectal discomfort associated with anorectal disorder or inflammation.

Warnings (For external use only)

Do not use this product if

• Pregnant or breastfeeding, ask a health professional before use.
• In case of accidental overdose, get medical help or contact Poison Control Center immediately.
• tamper evident "Do not use this product" If seal is broken or missing.

When using this product

• do not exceed the recommended daily dosage unless directed by doctor.
• Certain persons can develop allergic reactions to ingredients in this product.
• Do not put this product into the rectum by using ‑nger or any medical device or applicator.

Stop use and ask doctor if

the symptoms being treated does not subside, or if redness, Irritation, swelling pain or other symptoms develop or increase.

Keep out of reach of the children.

In case of accidental ingestion, sook modical attention immediately.

Directions

• Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
• Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
• Apply up to 6 times a day.
• Children un 12 years of age consult a doctor.

Other Information

Keep away from direct sunlight or heat.

Store at room temperature 15° to 30°C (59° to 86°F)

Inactive ingredient

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purfied Water, Trolamine, Vitamin E Acetate

Questions ?

(407) 737-9424

Principal Primary Panel

NUMB CREAM

NDC: 82429-203-01

Lidocaine Cream 5%

NET WT 1.35 OZ (38g)

INGREDIENTS AND APPEARANCE

NUMB 
lidocaine 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82429-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
TROLAMINE (UNII: 9O3K93S3TK)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHOLESTEROL (UNII: 97C5T2UQ7J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82429-203-01	1 in 1 CARTON	10/10/2022
1		38 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	10/10/2022

Labeler - Gabar Health Sciences Corp. (118401847)

Registrant - Gabar Health Sciences Corp. (118401847)