Numb Cream

Numb Cream
SPL v2
SPL
SPL Set ID 11f4bf92-0dbd-a83e-e063-6394a90a739a
Route
TOPICAL
Published
Effective Date 2024-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Mentha Arvensis Leaf Portulaca Oleracea Seed Water Prilocaine Hydroxyacetophenone Chrysanthellum Indicum Top Carbomer Homopolymer, Unspecified Type Tetracaine Epinephrine Glycerin Propylene Glycol Magnesium Disodium Edta Borneol 1,2-hexanediol Peg-40 Hydrogenated Lanolin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-22

Description

Numb Cream


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For temporarily relieve local discomfort, itching, pain, soreness or burning sensation on hands, legs, back and other skin.

Dosage and Administration

1.For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly.

2.Apply externally to the affected area up to 6 times.

Description

Numb Cream

Section 42229-5

Numb Cream

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

lf swallowed accidentally, get medical help or contact with Poison Control Center immediately.

Section 50566-9

skin reactions such as redness.swelling, blistering or other discomfort occur.

Section 50567-7

Use only as directed.

Avoid contact with the eyes,

mucous membranes, or rashes.

Do not bandage tightly.

Section 50570-1

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

Section 51727-6

Water

Propylene Glycol

Carbomer

Glycerin

Disodium Edta

Hydroxyacetophenone

1.2-Hexanediol

Mentha Arvensis Leaf Extract

Chrysanthellum Indicum Extract

Portulaca Oleracea Extract

Peg-40 Hydrogenated Castor Oil

Epinephrine

Tetracaine

Prilocaine

Borneol

Section 51945-4

Section 55105-1

Topical Analgesic

Section 55106-9

LIDOCAINE 4%


Structured Label Content

Indications and Usage (34067-9)

For temporarily relieve local discomfort, itching, pain, soreness or burning sensation on hands, legs, back and other skin.

Dosage and Administration (34068-7)

1.For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly.

2.Apply externally to the affected area up to 6 times.

Warnings and Precautions (34071-1)

For external use only

Section 42229-5 (42229-5)

Numb Cream

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

lf swallowed accidentally, get medical help or contact with Poison Control Center immediately.

Section 50566-9 (50566-9)

skin reactions such as redness.swelling, blistering or other discomfort occur.

Section 50567-7 (50567-7)

Use only as directed.

Avoid contact with the eyes,

mucous membranes, or rashes.

Do not bandage tightly.

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Water

Propylene Glycol

Carbomer

Glycerin

Disodium Edta

Hydroxyacetophenone

1.2-Hexanediol

Mentha Arvensis Leaf Extract

Chrysanthellum Indicum Extract

Portulaca Oleracea Extract

Peg-40 Hydrogenated Castor Oil

Epinephrine

Tetracaine

Prilocaine

Borneol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

LIDOCAINE 4%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)