Otc - Active Ingredient
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)
Personal Lubricant
FDA Label NDC 52810-801
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puremedy for the product Personal Lubricant (NDC 52810-801). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, dosage & administration, inactive ingredient, warnings, otc - keep out of reach of children, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PROPERTIES
SKIN PROTECTANT
SKIN PROTECTANT
SKIN PROTECTANT
FOR VAGINAL DRYNESS
Indications & Usage
USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH DRYNESS, MILD CANDIDA, AND MINOR SORES. NOT TO BE USED SOME LATEX CONDOMS.
Dosage & Administration
DIRECTIONS: APPLY TO AFFECTED AREA AS NEEDED.
Inactive Ingredient
OTHER INGREDIENTS: ORGANIC OLIVE OIL, HIGH OLEIC SAFFLOWER OIL, ORGANIC BEESWAX, CANADIAN FIR BALSAM
Warnings
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
KEEP OUT OF REACH OF CHILDREN.
Otc - Questions
CUSTOMER SERVICE 310-526-6108
Other Safety Information
STORE IN A COOL DRY PLACE OR REFRIGERATE
* Please review the disclaimer below.
