Drug Facts

Manufacturer: Biostandard Inc.
Effective date: 2015-08-04
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:43:14

Label at a glance#

ProductCeravine Lip Balm

Active ingredientOATMEAL

Label structure8 sections

Indications and uses

Temporarily relieves pain and itching commonly associated with dryness Helps prevent and heal dry; chapped and cracked lips

Dosage and administration

Apply generously as needed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal (0.1%)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching commonly associated with dryness
Helps prevent and heal dry; chapped and cracked lips

Warnings

WARNINGS SECTION

If irritation or rash persists, consult a physician

Do not use on

OTC - DO NOT USE SECTION

cuts, scrapes, or broken skins

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash persists.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply generously as needed.

Other information

SPL UNCLASSIFIED SECTION

Store between 0 C to 28 C (62 F to 82.4 F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ricinus Communis (Castor) Seed Oil, Cera Alba (Beeswax), Olea Europaea (Olive) Fruit Oil, Helianthus Annus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Hydrogenated Vegetable Oil, Tocopherol, Citrus Sinensis (Orange) Oil, Mentha Piperita (Peppermint) Oil, Propolis Extract, Fibroin

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ceravine LIP BALM

100% Natural Ingredients

Net Wt. 0.17 oz (5g)

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
OATMEAL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61403-030-01	2020-01-31	C162847	48780-1	9d75b9d0-2164-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61403-030-01	Ceravine Lip Balm	1 in 1 CARTON	STICK	1		1
61403-030-01	Ceravine Lip Balm	5 g in 1 APPLICATOR	STICK	5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61403-030	CERAVINE LIP BALM (OATMEAL) STICK [BIOSTANDARD INC.]	1	Legacy NDC, 2 package rows	20150804_8d3d60bc-7ff2-42ec-bc15-f4770ca9e4e4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OATMEAL	ACTIVE INGREDIENT	8PI54V663Y	1
OATMEAL	ACTIVE MOIETY	8PI54V663Y	1
AVOCADO OIL	INACTIVE INGREDIENT	6VNO72PFC1	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	1
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	1
ORANGE OIL	INACTIVE INGREDIENT	AKN3KSD11B	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	1
PROPOLIS WAX	INACTIVE INGREDIENT	6Y8XYV2NOF	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Ceravine Lip Balm
Oatmeal
CASTOR OIL
YELLOW WAX
OLIVE OIL
SUNFLOWER OIL
AVOCADO OIL
TOCOPHEROL
ORANGE OIL
PEPPERMINT OIL
PROPOLIS WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61403-030	61403-030-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OATMEAL	8PI54V663Y	ACTIB
CASTOR OIL	D5340Y2I9G	IACT
YELLOW WAX	2ZA36H0S2V	IACT
OLIVE OIL	6UYK2W1W1E	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
AVOCADO OIL	6VNO72PFC1	IACT
TOCOPHEROL	R0ZB2556P8	IACT
ORANGE OIL	AKN3KSD11B	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
PROPOLIS WAX	6Y8XYV2NOF	IACT

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 2 · 62 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CASTOR OIL	CASTOR OIL	D5340Y2I9G	CAPSULE, EXTENDED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET / ORAL		17 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SUSPENSION / ORAL	100 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET / SUBLINGUAL	0.15 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	CAPSULE / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	PASTE, DENTIFRICE / DENTAL	49.3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	GEL / NASAL		429 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOAP / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	SPRAY / NASAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	OINTMENT / TOPICAL	14.9 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / ORAL		526 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	ELIXIR / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SOLUTION / DENTAL	0.04 %v/v		Exact identifier — unii candidate 21 equally ranked IID candidates
ORANGE OIL	ORANGE OIL, COLD PRESSED	AKN3KSD11B	LIQUID / ORAL	50 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	INJECTION, EMULSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 5 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	EMULSION / OPHTHALMIC		32 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE, EXTENDED RELEASE / ORAL	80.67 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
ORANGE OIL	ORANGE OIL, COLD PRESSED	AKN3KSD11B	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SYRUP / ORAL		120 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, COATED / ORAL	0.9 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, DELAYED RELEASE / ORAL	0.1 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	GRANULE, FOR SUSPENSION / ORAL		128 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	TABLET / ORAL	0.08 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET / ORAL		28 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / BUCCAL		526 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / TOPICAL	0.6 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SPRAY, METERED / SUBLINGUAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, FILM COATED / ORAL	15.29 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	INJECTION, SOLUTION / INTRAMUSCULAR		525 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET / SUBLINGUAL	1.6 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / ORAL	425 mg/1ml		Exact identifier — unii candidate 5 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	LOZENGE / ORAL		12 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ORANGE OIL	ORANGE OIL, COLD PRESSED	AKN3KSD11B	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	INJECTION / INTRAMUSCULAR		885 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	CONCENTRATE / ORAL	0.05 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	CAPSULE / ORAL		60 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
ORANGE OIL	ORANGE OIL, COLD PRESSED	AKN3KSD11B	ELIXIR / ORAL	0.24 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, COATED / ORAL	213.7 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
ORANGE OIL	ORANGE OIL, COLD PRESSED	AKN3KSD11B	POWDER, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, EXTENDED RELEASE / ORAL	23.27 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	FILM / BUCCAL		12 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SOLUTION / ORAL		53 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	LOTION / TOPICAL		32468 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE / ORAL		44 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ORANGE OIL	ORANGE OIL, COLD PRESSED	AKN3KSD11B	TABLET, CHEWABLE / ORAL	3.7 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	SOLUTION / TOPICAL	1.38 %w/w		Exact identifier — unii candidate 16 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
564e7052-6226-442f-a229-f7839d93b4e3			8d3d60bc-7ff2-42ec-bc15-f4770ca9e4e4	2015-08-04	Warnings	Exact identifier spl id: 564e7052-6226-442f-a229-f7839d93b4e3 spl set id: 8d3d60bc-7ff2-42ec-bc15-f4770ca9e4e4

Reported adverse events (FAERS/openFDA)#

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