PERSONAL LUBRICANT

Manufacturer: PUREMEDY
Effective date: 2021-10-06
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 02:15:14

Label at a glance#

ProductPERSONAL LUBRICANT

Active ingredientSAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, PINE NEEDLE OIL (PINUS SYLVESTRIS), BERBERIS VULGARIS FRUIT

Label structure10 sections

Contacts and useful links#

PhoneLabel contact310-526-6108

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

ORG. SAMBUCUS NIGRA (2X) HPUS (ELDERBERRY)

ORG. CALENDULA OFFICINALIS (2X) HPUS) (MARIGOLD)

PINUS SILVESTRIS (2X) HPUS (PINE RESIN)

BERBERIS VULGARIS (3X) HPUS (BARBERRY)

OTC - PURPOSE SECTION

PROPERTIES

SKIN PROTECTANT

FOR VAGINAL DRYNESS

INDICATIONS & USAGE SECTION

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH DRYNESS, MILD CANDIDA, AND MINOR SORES. NOT TO BE USED SOME LATEX CONDOMS.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: APPLY TO AFFECTED AREA AS NEEDED.

INACTIVE INGREDIENT SECTION

OTHER INGREDIENTS: ORGANIC OLIVE OIL, HIGH OLEIC SAFFLOWER OIL, ORGANIC BEESWAX, CANADIAN FIR BALSAM

WARNINGS SECTION

WARNING: TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN FIRST. DO NOT USE IF ALLERGIC TO OR HYPER-SENSITIVE TO ANY INGREDIENT IN THIS SALVE. IF CONDITION PERSISTS OR WORSENS CONSULT YOUR HEALTH CARE PROVIDER. (* = CERTIFIED ORGANIC INGREDIENTS)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

OTC - QUESTIONS SECTION

CUSTOMER SERVICE 310-526-6108

OTHER SAFETY INFORMATION

STORE IN A COOL DRY PLACE OR REFRIGERATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

personal 1 oz

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
52810-801-11	2023-01-30	C162847	48780-1	9855d018-e408-cd31-e053-dbdaa90ab51a	PERSONAL LUBRICANT (52810-801)
52810-801-11	2020-05-21	C162847	48780-1	9855d018-e408-cd31-e053-dbdaa90ab51a	PERSONAL LUBRICANT (52810-801)
52810-801-11	2019-11-27	C162847	48780-1	9855d018-e408-cd31-e053-dbdaa90ab51a	PERSONAL LUBRICANT (52810-801)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52810-801-11	PERSONAL LUBRICANT	30 mL in 1 JAR	SALVE	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52810-801	PERSONAL LUBRICANT (SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER PINE NEEDLE OIL (PINUS SYLVESTRIS)) SALVE [PUREMEDY]	4	Legacy NDC, 1 package rows	20211221_be1abf93-6898-461f-ad34-e93a655f4315.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BERBERIS VULGARIS FRUIT	ACTIVE INGREDIENT	6XEF22AHC3	2
CALENDULA OFFICINALIS FLOWER	ACTIVE INGREDIENT	P0M7O4Y7YD	2
PINE NEEDLE OIL (PINUS SYLVESTRIS)	ACTIVE INGREDIENT	5EXL5H740Y	2
SAMBUCUS NIGRA FLOWER	ACTIVE INGREDIENT	07V4DX094T	2
BERBERIS VULGARIS FRUIT	ACTIVE MOIETY	6XEF22AHC3	2
CALENDULA OFFICINALIS FLOWER	ACTIVE MOIETY	P0M7O4Y7YD	2
PINE NEEDLE OIL (PINUS SYLVESTRIS)	ACTIVE MOIETY	5EXL5H740Y	2
SAMBUCUS NIGRA FLOWER	ACTIVE MOIETY	07V4DX094T	2
CANADA BALSAM	INACTIVE INGREDIENT	K304VI98I3	2
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	2
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	2

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

PERSONAL LUBRICANT
SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER PINE NEEDLE OIL (PINUS SYLVESTRIS)
OLIVE OIL
SAFFLOWER OIL
YELLOW WAX
CANADA BALSAM
SAMBUCUS NIGRA FLOWER
CALENDULA OFFICINALIS FLOWER
PINE NEEDLE OIL (PINUS SYLVESTRIS)
BERBERIS VULGARIS FRUIT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52810-801	52810-801-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OLIVE OIL	6UYK2W1W1E	IACT
SAFFLOWER OIL	65UEH262IS	IACT
YELLOW WAX	2ZA36H0S2V	IACT
CANADA BALSAM	K304VI98I3	IACT
SAMBUCUS NIGRA FLOWER	07V4DX094T	ACTIB
CALENDULA OFFICINALIS FLOWER	P0M7O4Y7YD	ACTIB
PINE NEEDLE OIL (PINUS SYLVESTRIS)	5EXL5H740Y	ACTIB
BERBERIS VULGARIS FRUIT	6XEF22AHC3	ACTIB

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 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE / ORAL		44 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
SAFFLOWER OIL	SAFFLOWER OIL	65UEH262IS	LOTION / TOPICAL		3510 mg	Exact identifier — unii candidate
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	LOTION / TOPICAL		32468 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
CANADA BALSAM	CANADA BALSAM	K304VI98I3	LOTION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	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
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, COATED / ORAL	213.7 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / ORAL	425 mg/1ml		Exact identifier — unii candidate 5 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
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / TOPICAL	0.6 %w/w		Exact identifier — unii candidate 5 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
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOAP / TOPICAL	NA		Exact identifier — unii candidate 5 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
cdb77b15-9fc6-5f36-e053-2a95a90a1e12			be1abf93-6898-461f-ad34-e93a655f4315	2021-10-06	Warnings	Exact identifier spl id: cdb77b15-9fc6-5f36-e053-2a95a90a1e12 spl set id: be1abf93-6898-461f-ad34-e93a655f4315

Reported adverse events (FAERS/openFDA)#

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