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NDC 11822-9972-09 Therapeutic 1.02 mg/mL Details

Therapeutic 1.02 mg/mL

Therapeutic is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid. The primary component is COAL TAR.

Product Information

NDC	11822-9972
Product ID	11822-9972_c56b6a71-d550-42e4-9f4e-4fecdef3627b
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	Therapeutic
Proprietary Name Suffix	n/a
Non-Proprietary Name	Coal Tar
Product Type	HUMAN OTC DRUG
Dosage Form	SHAMPOO
Route	TOPICAL
Active Ingredient Strength	1.02
Active Ingredient Units	mg/mL
Substance Name	COAL TAR
Labeler Name	Rite Aid
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 11822-9972-09 (11822997209)

Pricing Information	N/A
NDC Package Code	11822-9972-9
Billing NDC	11822997209
Package	1 BOTTLE, PLASTIC in 1 CARTON (11822-9972-9) / 177 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2016-05-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 35430ff4-d4ff-4102-a352-69496ff5b709 Details

Active ingredient

5% Coal tar topical solution USP (1% Coal tar)

Purpose

Anti-dandruff, Anti-seborrheic dermatitis, Anti-psoriasis

Use

controls the symoptoms of:

dandruff
seborrheic dermatitis
psoriasis

Warnings

For external use only

Ask a doctor before use if you have

a condition which covers a large part of the body

When using this product

do not get into eyes. If contact occurrs, rinse eyes thoroughly with water
use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application
do not use for prolonged periods without consulting a doctor
do not use with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor

Stop use and ask a doctor if

condition worsens or does not improve after reqular use of this product as directed.

Keep out of reach of children.

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

California Proposition 65 Warning

This product contains chemicals know in the State of California to cause cancer.

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 away from direct sunlight
in rare instances, discoloration of gray, blonde, bleached or tinted hair may occur

Inactive ingredients

water, sodium laureth sulfate, cocamide MEA, cocamidipropyl betaine, polysorbate 20, laureth-4, bishydroxyethly dihydroxypropyl stearammonium chloride, PEG-120 methyl glucose dioleate, tetrasodium EDTA, citric acid, fragrance, methylparaben, propylparaben, caramel, red-4

Questions or comments?

1-(800)-748-3243

SPL UNCLASSIFIED SECTION

COAL TAR therapeutic DANDRUFF SHAMPOO EXTRA STRENGTH

Controls the Symptoms of Dandruff, Psoriasis & Seborrheic Dermatitis

With 5% Coal Tar Topical Solution USP (1% Coal Tar)

*This product is not manufactured or distributed by the Neutorgena T/Gel Therapeutic Shampoo Extra Strength.

DISTRIBUTED BY: RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

MADE IN THE U.S.A. WITH FOREIGN AND DOMESTIC COMPONENTS

look great feel great

100% GUARANTEE or your money back

principal display panel

daylogic

COAL TAR therapeutic DANDRUFF SHAMPOO EXTRA STRENGTH

Controls the Symptoms of Dandruff, Psoriasis & Seborrheic Dermatitis

With 5% Coal Tar Topical Solution USP (1% Coal Tar)

Compare to Neutrogena T/Gel*

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

THERAPEUTIC

coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-9972
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	1.02 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LAURETH-4 (UNII: 6HQ855798J)
BISHYDROXYETHYL DIHYDROXYPROPYL STEARAMMONIUM CHLORIDE (UNII: 32II08O72A)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CARAMEL (UNII: T9D99G2B1R)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-9972-9	1 in 1 CARTON	05/02/2016
1		177 mL 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 final	part358H	05/02/2016

Labeler - Rite Aid (014578892)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(11822-9972)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(11822-9972)

Revised: 3/2022

Document Id: c56b6a71-d550-42e4-9f4e-4fecdef3627b

Set id: 35430ff4-d4ff-4102-a352-69496ff5b709

Version: 9

Effective Time: 20220303