Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient Purpose Pyrithione Zinc 1% Anti-dandruff
OTC - PURPOSE SECTION
Help prevent the scalp's natural moisture balance and gives you great looking hair.
Royal dandruff Dry Scalp Care
- Manufacturer
- Filo America | NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.
- Effective date
- 2013-09-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:36:55
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
Shake well, wet hair, massage onto scalp. Rinse, repeat if desired. For best results, use at least twice a week or as directed by a doctor. For maximum dandruff control, use every time you shampoo.
Warnings
WARNINGS SECTION
For external use only. Stop use and ask a doctor if Condition worsens or does not improve after regular use as directed.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
apply as needed.
Other Label Information
INACTIVE INGREDIENT SECTION
water, sodium laureth sulfate, cocamidopropyl betaine, sodium lauroamphoacetate, glycol stearate, acrylates/acrylamide copolymer, ammonium chloride, methylchloroisothiazolinone, methylisothiazolinone, fragrance, citric acid, guar hydroxypropyltrimonium chloride, titanium dioxide, disodium EDTA, zinc chloride, blue 1, yellow 5
Label Images#
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50438-300-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d481-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50438-300-01 | Royal dandruff Dry Scalp Care | 350 mL in 1 BOTTLE | SHAMPOO | 350 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PYRITHIONE ZINC | ACTIVE INGREDIENT | R953O2RHZ5 | 1 | |
| PYRITHIONE ZINC | ACTIVE MOIETY | R953O2RHZ5 | 1 | |
| ammonium chloride | INACTIVE INGREDIENT | 01Q9PC255D | 1 | |
| CARBOMER COPOLYMER TYPE A | INACTIVE INGREDIENT | 71DD5V995L | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| cocamidopropyl betaine | INACTIVE INGREDIENT | 5OCF3O11KX | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| glycol stearate | INACTIVE INGREDIENT | 0324G66D0E | 1 | |
| methylchloroisothiazolinone | INACTIVE INGREDIENT | DEL7T5QRPN | 1 | |
| methylisothiazolinone | INACTIVE INGREDIENT | 229D0E1QFA | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
- Royal dandruff Dry Scalp Care
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50438-300 | 50438-300-01 |
Ingredients#
Complete SPL Sections#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient Purpose Pyrithione Zinc 1% Anti-dandruff
OTC - PURPOSE SECTION
Help prevent the scalp's natural moisture balance and gives you great looking hair.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If swallowed, get medical help or contact a Poison Control Center right away. Do not get into eyes, if contact occurs, rinse eyes thoroughly with water.
INDICATIONS & USAGE SECTION
Shake well, wet hair, massage onto scalp. Rinse, repeat if desired. For best results, use at least twice a week or as directed by a doctor. For maximum dandruff control, use every time you shampoo.
WARNINGS SECTION
For external use only. Stop use and ask a doctor if Condition worsens or does not improve after regular use as directed.
DOSAGE & ADMINISTRATION SECTION
apply as needed.
INACTIVE INGREDIENT SECTION
water, sodium laureth sulfate, cocamidopropyl betaine, sodium lauroamphoacetate, glycol stearate, acrylates/acrylamide copolymer, ammonium chloride, methylchloroisothiazolinone, methylisothiazolinone, fragrance, citric acid, guar hydroxypropyltrimonium chloride, titanium dioxide, disodium EDTA, zinc chloride, blue 1, yellow 5