NUMBSURE LIDOCAINE- lidocaine cream

Numbsure LIDOCAINE by

Drug Labeling and Warnings

Numbsure LIDOCAINE by is a Otc medication manufactured, distributed, or labeled by Hambli Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

(For external use only)
When using this product:

Avoid contact with eyes.
Do not exceed recommended dosage unless directed
by a doctor.
Do not put this product into the rectum by using fingers
or any mechanical device or applicator.
Stop use and ask a doctor if:
Rectal bleeding occurs.
Condition worsens or does not improve within 7 days.
Allergic reaction occurs to ingredients in this product.
Symptom being treated does not subside or if redness
irritation, swelling, pain or other symptoms develop or
increase symptoms clear up and return within a few days.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions
When practical, clean area with mild soap and warm
water and rinse thoroughly. Gently dry by patting or
blotting with toilet tissue or soft cloth before applying.
Adults and children 12 years and older:
apply externally to the affected area up to 6 times a day.

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INACTIVE INGREDIENT

Inactive Ingredients
Water, Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/
Sodium Acryloyldimethyl Taurate Copolymer, Caprylic/
Capric Triglyceride, Tocopheryl Acetate, Arginine,
Phenoxyethanol, Chlorphenesin

INDICATIONS & USAGE

Uses
Helps relieve the pain, itching and burning associated with
hemorrhoids and other anorectal disorders.

Avoid contact with eyes.
Do not exceed recommended dosage unless directed
by a doctor.
Do not put this product into the rectum by using fingers
or any mechanical device or applicator.
Stop use and ask a doctor if:
Rectal bleeding occurs.
Condition worsens or does not improve within 7 days.
Allergic reaction occurs to ingredients in this product.
Symptom being treated does not subside or if redness
irritation, swelling, pain or other symptoms develop or
increase symptoms clear up and return within a few days.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away.

PURPOSE

Local anesthetic

ACTIVE INGREDIENT

Lidocaine 5%.

Pregnancy Section

Consult your doctor before using it

DRUG FACTS

DRUG FACTS
Active Ingredient
Lidocaine 5%.

Uses
Helps relieve the pain, itching and burning associated with
hemorrhoids and other anorectal disorders.

Warnings (For external use only)
When using this product:

Avoid contact with eyes.
Do not exceed recommended dosage unless directed
by a doctor.
Do not put this product into the rectum by using fingers
or any mechanical device or applicator.
Stop use and ask a doctor if:
Rectal bleeding occurs.
Condition worsens or does not improve within 7 days.
Allergic reaction occurs to ingredients in this product.
Symptom being treated does not subside or if redness
irritation, swelling, pain or other symptoms develop or
increase symptoms clear up and return within a few days.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away.

Purpose
Local anesthetic

DRUG FACTS (Continued)
Directions
When practical, clean area with mild soap and warm
water and rinse thoroughly. Gently dry by patting or
blotting with toilet tissue or soft cloth before applying.
Adults and children 12 years and older:
apply externally to the affected area up to 6 times a day.
Children under 12 years of age: Consult a doctor.
To use finger cots: Roll one finger cot over finger.
Gently squeeze cream onto finger cot. Smooth a layer
of the cream over affected area.

Other Information
Store at 25°C (77°F); excursions permitted to 15-30C
(59-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients
Water, Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/
Sodium Acryloyldimethyl Taurate Copolymer, Caprylic/
Capric Triglyceride, Tocopheryl Acetate, Arginine,
Phenoxyethanol, Chlorphenesin

INGREDIENTS AND APPEARANCE

NUMBSURE LIDOCAINE 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83714-0002
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
CHLORPHENESIN (UNII: I670DAL4SZ)	0.15 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	7 g  in 100 g
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)	2 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.6 g  in 100 g
ARGININE (UNII: 94ZLA3W45F)	0.7 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)	1 g  in 100 g
WATER (UNII: 059QF0KO0R)	75.35 g  in 100 g
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)	3.2 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	5 g  in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83714-0002-1	1 in 1 PACKAGE	06/16/2025
1	NDC: 83714-0002-0	30 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/16/2025

Labeler - Hambli Limited (227713374)

Establishment
Name	Address	ID/FEI	Business Operations
Hambli Limited		227713374	manufacture(83714-0002)