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NDC 70000-0550-01 Leader Therapeutic Dandruff 30 mg/mL Details

Leader Therapeutic Dandruff 30 mg/mL

Leader Therapeutic Dandruff is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is SALICYLIC ACID.

MedlinePlus Drug Summary

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.

Related Packages: 70000-0550-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	70000-0550
Product ID	70000-0550_782516f2-a194-4e9f-aaea-f44a4d3c6a20
Associated GPIs	90750030004515
GCN Sequence Number	016173
GCN Sequence Number Description	salicylic acid SHAMPOO 3 % TOPICAL
HIC3	L5A
HIC3 Description	KERATOLYTICS
GCN	22824
HICL Sequence Number	002465
HICL Sequence Number Description	SALICYLIC ACID
Brand/Generic	Generic
Proprietary Name	Leader Therapeutic Dandruff
Proprietary Name Suffix	Anti-Dandruff, anti-seborrheic dematitis and anti-psoriasis
Non-Proprietary Name	Salicylic Acid
Product Type	HUMAN OTC DRUG
Dosage Form	SHAMPOO
Route	TOPICAL
Active Ingredient Strength	30
Active Ingredient Units	mg/mL
Substance Name	SALICYLIC ACID
Labeler Name	Cardinal Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358H
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0550-01 (70000055001)

Pricing Information
NDC Package Code	70000-0550-1
Billing NDC	70000055001
Package	133 mL in 1 BOTTLE, PLASTIC (70000-0550-1)
Marketing Start Date	2022-08-30
NDC Exclude Flag	N
Price Per Unit	0.02491
Pricing Unit	ML
Effective Date	2022-08-17
NDC Description	THERAPEUTIC 3% DANDRUFF SHMP
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2022-11-23

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 509434a9-50c4-4337-8e5b-17bdc667d23b Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 3.0%

Purpose

Anti-dandruff, anti-seborrheic dermatitis and anti-psoriasis

Uses

control the symptoms of

⬥: dandruff
⬥: seborrheic dermatitis
⬥: psoriasis

Warnings

For external use only

Ask a doctor before use if you have a condition which covers a large area of the body.

When using this product

⬥: avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

⬥: condition worsens or does not improve after regular use of this product as directed.

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

Directions

⬥: for best results use at least twice a week or as directed by a doctor
⬥: wet hair thoroughly
⬥: massage shampoo into scalp
⬥: lather, leave on hair and scalp for several minutes
⬥: rinse and repeat.

Other information

⬥: store at room temperature
⬥: store away from direct sunlight.

Inactive ingredients

water, sodium C14-16 olefin sulfonate, sodium laureth sulfate, cocamidopropyl betaine, cocamide MEA, PEG-150 distearate, polyquaternium-10, propylene glycol, sodium citrate, sodium hydroxide.

Questions or comments?

1-866-567-8600

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Label

LEADER™

NDC 70000-0550-1

Therapeutic

Dandruff

Shampoo

Salicylic Acid, 3%

Anti-Dandruff

Anti-Seborrheic Dermatitis

Anti-Psoriasis

Controls the

Symptoms of Psoriasis,

Seborrheic Dermatitis

& Dandruff

Clears & Helps Prevent

Scalp Buildup

Fragrance-Free

Dye-Free

Preservative-Free

COMPARE TO

NEUTROGENA® T/SAL®

active ingredient*

100% Money Back Guarantee

4.5 FL OZ (133 mL)

05-3791B

Principal Display Panel - 133 mL Bottle Label

INGREDIENTS AND APPEARANCE

LEADER THERAPEUTIC DANDRUFF ANTI-DANDRUFF, ANTI-SEBORRHEIC DEMATITIS AND ANTI-PSORIASIS

salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0550
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
Propylene Glycol (UNII: 6DC9Q167V3)
PEG-150 Distearate (UNII: 6F36Q0I0AC)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Sodium Hydroxide (UNII: 55X04QC32I)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0550-1	133 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part358H	08/30/2022

Labeler - Cardinal Health (063997360)

Registrant - Garcoa, Inc. (036464697)

Name	Address	ID/FEI	Business Operations
Establishment
Sigan Industries INC		255106239	MANUFACTURE(70000-0550)

Revised: 9/2022

Document Id: 782516f2-a194-4e9f-aaea-f44a4d3c6a20

Set id: 509434a9-50c4-4337-8e5b-17bdc667d23b

Version: 3

Effective Time: 20220906

Search by Drug Name or NDC

NDC 70000-0550-01 Leader Therapeutic Dandruff 30 mg/mL Details

Leader Therapeutic Dandruff 30 mg/mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 70000-0550-01 (70000055001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 509434a9-50c4-4337-8e5b-17bdc667d23b Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

When using this product

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Label

INGREDIENTS AND APPEARANCE

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