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NDC 00536-1139-28 Rugby Lidocaine 40 mg/g Details

Rugby Lidocaine 40 mg/g

Rugby Lidocaine is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	00536-1139
Product ID	0536-1139_b20041bc-3ba5-46c3-9f4c-c290d6b9567c
Associated GPIs	90850060103735
GCN Sequence Number	075061
GCN Sequence Number Description	lidocaine HCl CREAM (G) 4 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	39982
HICL Sequence Number	001478
HICL Sequence Number Description	LIDOCAINE HCL
Brand/Generic	Generic
Proprietary Name	Rugby Lidocaine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	40
Active Ingredient Units	mg/g
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	Rugby Laboratories
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00536-1139-28 (00536113928)

Pricing Information	N/A
NDC Package Code	0536-1139-28
Billing NDC	00536113928
Package	1 TUBE in 1 CARTON (0536-1139-28) / 30 g in 1 TUBE
Marketing Start Date	2018-11-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 56b4b8e9-ab92-4635-b9ec-aa6f5390101f Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Lidocaine HCL 4%

Purpose

Topical anesthetic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do not use

on large areas of the body or on cut,irritated or swollen skin
on puncture wounds
for more than one week without consultanting a doctor

When using this product

use only as directed. read and follow all directions and warnings on this carton.

do notallow contact with the eyes

do not bandage or apply local heat (such as heating pads) to the area of use.

Stop use and ask a doctor if

condition worsens
symptons persist for more than 7 days or clear up and occur again within a few days.
If pregnant or breast feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children and pets.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

Adults and children over 12 years:
apply a thin layer ot affected area every 6 t o8 hours, not to exceed 3 applications in a 24 hour period
Children under 12 years or younger: ask a doctor

Other information

Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Phenoxyethanol, SD Alcohol 40, Steareth-21, Water (purified)

Questions?(800)645-2158

Principal Panel-Tube

RUGBY® NDC 0536-1139-20

Maxium Strength

4% Lidocaine

Pain Relieving Cream

NET WT. 15g (0.52 oz)

Principal Panel - Carton