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NDC 69315-0301-30 RectaSmoothe 5 g/100g Details

RectaSmoothe 5 g/100g

RectaSmoothe is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Leading Pharma, LLC. The primary component is LIDOCAINE.

Product Information

NDC	69315-0301
Product ID	69315-301_97a3ef32-4387-45ae-80b9-faceaf833a9c
Associated GPIs	89200025003720
GCN Sequence Number	040261
GCN Sequence Number Description	lidocaine CREAM (G) 5 % TOPICAL
HIC3	Q3H
HIC3 Description	HEMORRHOIDALS, LOCAL RECTAL ANESTHETICS
GCN	95404
HICL Sequence Number	010705
HICL Sequence Number Description	LIDOCAINE
Brand/Generic	Generic
Proprietary Name	RectaSmoothe
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine 5%
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	5
Active Ingredient Units	g/100g
Substance Name	LIDOCAINE
Labeler Name	Leading Pharma, LLC
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69315-0301-30 (69315030130)

Pricing Information
NDC Package Code	69315-301-30
Billing NDC	69315030130
Package	1 TUBE in 1 CARTON (69315-301-30) / 30 g in 1 TUBE
Marketing Start Date	2016-05-15
NDC Exclude Flag	N
Price Per Unit	0.45798
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	RECTASMOOTHE 5% CREAM
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 78120481-b780-4e41-885d-11e424d1f717 Details

Active Ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

Helps relive the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

WARNINGS:

For external use only.

When using this product

avoid contact with the eyes
do not exceed recommended dosage unless directed by a doctor
do not put this product into the rectum by using fingers or any other mechanical device or applicator

Stop use and ask doctor if

rectal bleeding occurs
condition worsens or does not improve within 7 days
allergic reaction occurs to ingredients in this product
symptom being treated does not suside or if redness, irritation swelling, pain or other symptoms develop or increase
symptoms clear up and return within a few days

Keep out of the reach of children

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

Directions

When practical, clean area with mild soap and warm water and rinse thouroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
Adults and children 12 years and older: Apply externally to the affected area up to six times a day.
Children under 12 years of age: Consult a doctor
To use finger cots: Roll one finger cot over finger. FGently squeeze cream onto finger cot. Smooth a layer of the cream over the affected area.

Other Information

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

cetyl alcohol, glyceryl monostearate SE, methylparaben, propylene glycol, propylparaben, purified water, white petrolatum, white wax

Lidocaine 5%

INGREDIENTS AND APPEARANCE

RECTASMOOTHE

lidocaine 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69315-301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4T6H12BN9U)
WHITE WAX (UNII: 7G1J5DA97F)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69315-301-30	1 in 1 CARTON	05/15/2016
1		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 final	part346	04/01/2011

Labeler - Leading Pharma, LLC (079575060)

Registrant - Leading Pharma, LLC (079575060)

Name	Address	ID/FEI	Business Operations
Establishment
Lyne Laboratories, Inc.		053510459	MANUFACTURE(69315-301)

Revised: 12/2017

Document Id: 97a3ef32-4387-45ae-80b9-faceaf833a9c

Set id: 78120481-b780-4e41-885d-11e424d1f717

Version: 2

Effective Time: 20171223