MedPath

Tagrid ANTI FUNGAL

Approved
Approval ID

3376b104-1f07-fab3-e063-6394a90a0ca4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 22, 2025

Manufacturers
FDA

TAGRID LLC

DUNS: 118778969

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Zinc Pyrithione,Salicylic Acid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85384-0005
Application NumberM032
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Pyrithione,Salicylic Acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 22, 2025
FDA Product Classification

INGREDIENTS (12)

STEMONA TUBEROSA ROOTInactive
Code: 7S9328671Z
Classification: IACT
BASSIA SCOPARIA FRUITInactive
Code: 04W97Z676Y
Classification: IACT
CNIDIUM MONNIERI FRUITInactive
Code: V1IA3S3CUS
Classification: IACT
ZINGIBER OFFICINALE WHOLEInactive
Code: IN6Q3S3414
Classification: IACT
PLATYCLADUS ORIENTALIS LEAFInactive
Code: 32E5V7G32B
Classification: IACT
SALICYLIC ACIDActive
Quantity: 0.02 g in 1 mL
Code: O414PZ4LPZ
Classification: ACTIB
SAUROMATUM GIGANTEUM WHOLEInactive
Code: C61Y66MY4H
Classification: IACT
REYNOUTRIA MULTIFLORA ROOTInactive
Code: AUZ3VD75MC
Classification: IACT
MENTHA CANADENSIS WHOLEInactive
Code: J1BO4MHT2L
Classification: IACT
DRYOBALANOPS AROMATICA RESINInactive
Code: 15HNY2J7SS
Classification: IACT
GLEDITSIA SINENSIS FRUITInactive
Code: A6W0J6UO7Q
Classification: IACT
ZINC PYRITHIONEActive
Quantity: 0.01 g in 1 mL
Code: R953O2RHZ5
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/22/2025

package

ANTIFUNGALSHAMPOO.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/22/2025

Uses:

  1. Controls dandruff, flaking, and itching
  2. Helps relieve symptoms of seborrheic dermatitis
  3. Clears scalp buildup and supports healthy scalp environment

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/22/2025

Active ingredient:

  1. Zinc Pyrithione 1%
  2. Salicylic Acid 2%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/22/2025

1.Purpose 1: Anti-Dandruff ( Active ingredient:Zinc Pyrithione 1% ) 2.Purpose 2: Anti-seborrheic dermatitis ( Active ingredient:Salicylic Acid 2% )

WARNINGS SECTION

LOINC: 34071-1Updated: 5/22/2025

For external use only

On broken or irritated skin.

Ask a doctor before use if you have:
• Sensitive skin

When using this product

• Avoid contact with eyes. If contact occurs, rinse thoroughly.

Stop use and ask a doctor if
• Condition worsens or does not improve

If pregnant or breast-feeding
• Ask a health professional before use

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/22/2025

Directions:

  1. Shake well before use
  2. Apply to wet scalp
  3. Gently massage and leave on for 3-5 minutes
  4. Rinse thoroughly
  5. Use 2-3 times weekly, or as directed by your dermatologist

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/22/2025

Other information:

  1. store at 20°C to 25°C (68°F-77°F)
  2. see top panel for lot number and expiration date

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/22/2025

Inactive ingredients:

  • Salicylic Acid
  • Zinc Pyrithione
  • Stemona Tuberosa Root
  • Bassia Scoparia Fruit
  • Zingiber Officinale Whole
  • Platycladus Orientalis Leaf
  • Sauromatum Giganteum Whole
  • Reynoutria Multiflora Root
  • Mentha Canadensis Whole
  • Dryobalanops Aromatica Resin
  • Gleditsia Sinensis Fruit
  • Cnidium Monnieri Fruit

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/22/2025

Questions or comments?
Contact us at support@tagridstore.com

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