FDA.reportPublic FDA data

Roccos Old School

Manufacturer
Roccos Old School | Creations Garden Natural Products Inc.
Effective date
2011-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:28:17

Label at a glance#

ProductRoccos Old School Healing Balm
Active ingredientZINC OXIDE
Label structure11 sections

Dosage and administration

Apply balm liberally as often as necessary.

Storage and handling

Store at controlled room temperature. Do not store above 105°F.

Label contents#

Full prescribing information#

Active Ingredient: Purpose:

OTC - ACTIVE INGREDIENT SECTION

Zince Oxide 3%................................Skin Prorectant

Use:

OTC - PURPOSE SECTION

  • To promote healing of minor skin irritations and sunburn.

Warnings:

WARNINGS SECTION

For external use only-skin. Flammable. Keep away from heat and flame.

When using this product

INDICATIONS & USAGE SECTION

  • Avoid contact with the eyes. In case of contact with eyes, flush thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worses or does not improve.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center Immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply balm liberally as often as necessary.

Other information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature.
  • Do not store above 105°F.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mangifera Indica (Mango) Seed Butter, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea Butter) Fruit, Beeswax, Agave Americana Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cannibis Sativia (Hemp) Seed Oil, Persea Gratissima (Avocado) Oil, Caprylic/Capric Triglyceride (and) Gylceryl Isostearate (and) Polyhydroxystearic Acid, and Natural Fragrance

Questions?

OTC - QUESTIONS SECTION

661-877-4280

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Placeholder Text


Roccos_Healing_Balm_30mL_label
Roccos_Healing_Balm_30mL_label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1112730Rocco's Old School Healing Balm 3 % Topical CreamPSN1
1112726zinc oxide 3 % Topical CreamPSN1
1112730zinc oxide 30 MG/ML Topical Cream [Rocco's Old School Healing Balm]SBD1
1112726zinc oxide 30 MG/ML Topical CreamSCD1
1112730Rocco's Old School Healing Balm 3 % Topical CreamSY1
1112730Rocco's Old School Healing Balm 30 MG/ML Topical CreamSY1
1112726ZNO 30 MG/ML Topical CreamSY1
1112730ZNO 30 MG/ML Topical Cream [Rocco's Old School Healing Balm]SY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24488-010-102019-10-29C16284748780-1960f7f55-d5dd-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24488-010-10Roccos Old SchoolHealing Balm30 mL in 1 CANISTERCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24488-010ROCCOS OLD SCHOOL HEALING BALM (ZINC OXIDE) CREAM [ROCCOS OLD SCHOOL]1Legacy NDC, 1 package rows20110615_95ae368c-35ed-4c3a-a5ca-a4e09f43fc4a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
AGAVE AMERICANA LEAFINACTIVE INGREDIENT8511ZMP5QK1
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC11
CANNABIS SATIVA SEED OILINACTIVE INGREDIENT69VJ1LPN1S1
COCONUTINACTIVE INGREDIENT3RT3536DHY1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L1
GLYCERYL ISOSTEARATEINACTIVE INGREDIENTHYE7O27HAO1
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
LIMEINACTIVE INGREDIENTC7X2M0VVNH1
MANGIFERA INDICA SEED BUTTERINACTIVE INGREDIENT4OXD9M35X21
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0F1
SHEANUTINACTIVE INGREDIENT84H6HBP32L1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G1
VERBENA HASTATA ROOTINACTIVE INGREDIENTLJ96XN173E1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24488-01024488-010-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
COCONUT OILQ9L0O73W7LIACT
SHEANUT84H6HBP32LIACT
YELLOW WAX2ZA36H0S2VIACT
AGAVE AMERICANA LEAF8511ZMP5QKIACT
JOJOBA OIL724GKU717MIACT
TEA TREE OILVIF565UC2GIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
AVOCADO OIL6VNO72PFC1IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
COCONUT3RT3536DHYIACT
LIMEC7X2M0VVNHIACT
VERBENA HASTATA ROOTLJ96XN173EIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 37 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY, METERED / SUBLINGUAL110 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
18 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, EMULSION / INTRAVENOUS1.1 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERYL ISOSTEARATEGLYCERYL ISOSTEARATEHYE7O27HAOCREAM / VAGINAL135 mgExact identifier — unii candidate
2 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LCAPSULE, LIQUID FILLED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS990.3 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER / SUBLINGUAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LOINTMENT / TOPICAL14.75 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
LIMELIME (CALCIUM OXIDE)C7X2M0VVNHCAPSULE / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
LIMELIME (CALCIUM OXIDE)C7X2M0VVNHSOLUTION, CONCENTRATE / ORAL0.1 ml/1mlExact identifier — unii candidate
2 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERYL ISOSTEARATEGLYCERYL ISOSTEARATEHYE7O27HAOCREAM / TOPICAL2 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fe61b4b2-3575-4817-9f7c-166f7e84d82e95ae368c-35ed-4c3a-a5ca-a4e09f43fc4a2011-02-17WarningsExact identifier
spl id: fe61b4b2-3575-4817-9f7c-166f7e84d82e
spl set id: 95ae368c-35ed-4c3a-a5ca-a4e09f43fc4a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.