2 in 1 Dandruff — v11

2 in 1 Dandruff

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Version

v11

Effective date

September 23, 2025

Original packager

Yes

Sections captured

14

Identifiers

Document ID
3f7dbf67-0be8-25d1-e063-6394a90ad0e3
Set ID
a58b9119-2adb-459f-86f4-95df28a430c5
Application numbers
M032
Product NDCs
37808-612
Package NDCs
37808-612-15, 37808-612-32, 37808-612-35
Original packager NDCs
—

Names & Manufacturers

Brand names
2 in 1 Dandruff
Generic names
PYRITHIONE ZINC
Manufacturer names
H E B
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
PYRITHIONE ZINC
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
209884
UNII
R953O2RHZ5
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Pyrithione zinc 1%
Adverse Reactions (1)

Sequence 1

ADVERSE REACTION MADE WITH PRIDE AND CARE FOR H-E-B ® , SAN ANTONIO, TX 78204 100% GUARANTEE If you aren't completely pleased with this product, we'll be happy to replace it or refund your money. You have our word on it.
Dosage And Administration (1)

Sequence 1

Directions shake well for maximum dandruff control, use every time you shampoo wet hair, massage onto scalp, rinse, repeat if desired for best results use at least twice a week or as directed by a doctor
Inactive Ingredient (1)

Sequence 1

Inactive ingredients water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5
Indications And Usage (1)

Sequence 1

Use helps prevent recurrence of flaking and itching associated with dandruff
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

principal display panel H-E-B ® DANDRUFF 2-IN-1 SHAMPOO + CONDITIONER WITH PYRITHIONE ZINC CLEAN APPLE REFRESHING AND CLEAN Leaves Hair Healthy-Looking & HELPS RELIEVE DRY SCALP 12.5 FL OZ (370 mL) image description image description
Purpose (1)

Sequence 1

Purpose Anti-dandruff
Questions (1)

Sequence 1

Questions? Call 1-888-593-0593
Spl Product Data Elements (1)

Sequence 1

2 in 1 Dandruff Pyrithione zinc WATER SODIUM LAURYL SULFATE SODIUM LAURETH SULFATE GLYCOL DISTEARATE SODIUM CHLORIDE ZINC CARBONATE SODIUM XYLENESULFONATE AMODIMETHICONE (800 CST) COCAMIDOPROPYL BETAINE SODIUM BENZOATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) MAGNESIUM CARBONATE HYDROXIDE CITRIC ACID MONOHYDRATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 PYRITHIONE ZINC PYRITHIONE ZINC
Spl Unclassified Section (1)

Sequence 1

Claims DANDRUFF 2-IN-1 CLEAN APPLE Dandruff Care for Great-Looking Hair. Helps prevent flakes, relieve itch, irritation, and dry scalp.
Stop Use (1)

Sequence 1

Stop use and ask a doctor if condition worsens or does not improve after regular use as directed
Warnings (1)

Sequence 1

Warnings For external use only
When Using (1)

Sequence 1

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

OpenFDA raw payload

{'application_number': ['M032'],
 'brand_name': ['2 in 1 Dandruff'],
 'generic_name': ['PYRITHIONE ZINC'],
 'is_original_packager': [True],
 'manufacturer_name': ['H E B'],
 'package_ndc': ['37808-612-35', '37808-612-15', '37808-612-32'],
 'product_ndc': ['37808-612'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['209884'],
 'spl_id': ['3f7dbf67-0be8-25d1-e063-6394a90ad0e3'],
 'spl_set_id': ['a58b9119-2adb-459f-86f4-95df28a430c5'],
 'substance_name': ['PYRITHIONE ZINC'],
 'unii': ['R953O2RHZ5']}