Rugby Lidocaine (Lidocaine) Cream [Rugby Laboratories] -

RUGBY LIDOCAINE (LIDOCAINE) CREAM [RUGBY LABORATORIES]
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NDC	0536-1139-20, 0536-1139-28
Set ID	56b4b8e9-ab92-4635-b9ec-aa6f5390101f
Category	HUMAN OTC DRUG LABEL
Packager	Rugby Laboratories
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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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

RUGBY® NDC 0536-1139-20

Maxium Strength

4% Lidocaine

Pain Relieving Cream

NET WT. 15g (0.52 oz)

INGREDIENTS AND APPEARANCE

RUGBY LIDOCAINE
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1139
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SILICON (UNII: Z4152N8IUI)
ALCOHOL (UNII: 3K9958V90M)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARETH-21 (UNII: 53J3F32P58)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETEARETH-2 PHOSPHATE (UNII: 8NSU66JGZR)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0536-1139-20	1 in 1 CARTON	09/21/2018
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0536-1139-28	1 in 1 CARTON	11/27/2018
2		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/21/2018

Labeler - Rugby Laboratories (079246066)

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Medic

RUGBY LIDOCAINE (LIDOCAINE) CREAM [RUGBY LABORATORIES]

Do not use

When using this product

Stop use and ask a doctor if

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

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