Search by Drug Name or NDC

NDC 63868-0956-01 QC Lidocaine 4 g/100g Details

QC Lidocaine 4 g/100g

QC Lidocaine is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	63868-0956
Product ID	63868-956_b5e427ee-3b6a-04ef-e053-2a95a90ad8c7
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	QC Lidocaine
Proprietary Name Suffix	Maximum Strength
Non-Proprietary Name	Lidocaine HCl
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	Chain Drug Marketing Association
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 63868-0956-01 (63868095601)

Pricing Information	N/A
NDC Package Code	63868-956-01
Billing NDC	63868095601
Package	1 BOTTLE, PLASTIC in 1 CARTON (63868-956-01) / 49.6 g in 1 BOTTLE, PLASTIC
Marketing Start Date	2020-12-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b5e1b1ab-8a95-2d2d-e053-2995a90aea53 Details

Active Ingredient

Lidocaine HCl 4%

Purpose

Topical analgesic

Uses

temporarily relieves pain and itching due to:

minor burns

sunburn

minor cuts

scrapes

insect bites

minor skin irritations

Warnings

For external use only

Do not use

Do not use in large quantities, particularly over raw surfaces or blistered areas

When using this product

When using this product do not get into eyes

Stop use and ask a doctor if

condition gets worse

symptoms last for more than 7 days

symptoms clear up and occur again within a few days

Keep out of reach of children

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

Directions

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

Other information

store between 20 °C and 25 °C

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol,

C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monostearate, methylparaben, purified water, SD alcohol 40, steareth-21

Prinicpal display panel

Quality Choice

Maximum Strength Lidocaine Cream Lidocaine HCL 4 %- Topical Analgesic

Steroid free, Works on Contact

INGREDIENTS AND APPEARANCE

QC LIDOCAINE MAXIMUM STRENGTH

lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-956
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
STEARETH-21 (UNII: 53J3F32P58)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
ALCOHOL (UNII: 3K9958V90M)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-956-01	1 in 1 CARTON	12/07/2020
1		49.6 g in 1 BOTTLE, PLASTIC; 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	12/07/2020

Labeler - Chain Drug Marketing Association (011920774)

Registrant - Weeks & Leo Co., Inc. (005290028)

Name	Address	ID/FEI	Business Operations
Establishment
Weeks & Leo Co., Inc.		005290028	manufacture(63868-956)

Revised: 12/2020

Document Id: b5e427ee-3b6a-04ef-e053-2a95a90ad8c7

Set id: b5e1b1ab-8a95-2d2d-e053-2995a90aea53

Version: 1

Effective Time: 20201207