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NDC 11822-4215-01 Rite Aid Pain Relief Cream with Lidocaine 4 g/100g Details

Rite Aid Pain Relief Cream with Lidocaine 4 g/100g

Rite Aid Pain Relief Cream with Lidocaine is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	11822-4215
Product ID	11822-4215_dfefd57b-2024-877c-e053-2a95a90a6502
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Rite Aid Pain Relief Cream with Lidocaine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	g/100g
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	Rite Aid
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 11822-4215-01 (11822421501)

Pricing Information	N/A
NDC Package Code	11822-4215-1
Billing NDC	11822421501
Package	1 BOTTLE in 1 CARTON (11822-4215-1) / 76.5 g in 1 BOTTLE
Marketing Start Date	2022-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dfefd56c-50e3-aa25-e053-2995a90ac7f2 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Lidocaine HCI 4%

Purpose

Topical anesthetic

Uses

temporarily relieves minor pain

Warnings

For external use only. Avoid contact with eyes

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 consulting a doctor

When using this product

use only as directed. Read and follow all directions and warnings on this carton.
do not allow 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
symptoms 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 out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

adults and children over 12 years:

apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

children 12 years and younger: ask a doctor

Other Information

Store at room temperature

Inactive ingredients

aloe vera leaf, carbopol 940, cetostearyl alcohol, dimethicone 350, edetate disodium, glycerin, glyceryl monostearate, isopropyl alcohol, phenoxyethanol, polysorbate 60, steareth 2, steareth 21, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RITE AID PAIN RELIEF CREAM WITH LIDOCAINE

lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-4215
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 940 (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARETH-2 (UNII: V56DFE46J5)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARETH-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-4215-1	1 in 1 CARTON	05/01/2022
1		76.5 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:11822-4215-2	2 in 1 CARTON	05/01/2022
2		133 g in 1 BOTTLE; 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	05/01/2022

Labeler - Rite Aid (014578892)

Name	Address	ID/FEI	Business Operations
Establishment
ANICARE PHARMACEUTICALS PRIVATE LIMITED		916837425	manufacture(11822-4215)

Revised: 5/2022

Document Id: dfefd57b-2024-877c-e053-2a95a90a6502

Set id: dfefd56c-50e3-aa25-e053-2995a90ac7f2

Version: 1

Effective Time: 20220526