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Baby diaper rash - Medication Information

Product NDC Code 52810-216
Drug Name

Baby diaper rash

Type Brand
Active Ingredients
Calendula officinalis flower 1 [hp_x]/100ml
Sambucus nigra flower 1 [hp_x]/100ml
Route TOPICAL
Dosage Form SALVE
Labeler Name PUREMEDY
Packages
Package NDC Code Description
52810-216-11 30 ml in 1 jar (52810-216-11)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENTS ORG. CALENDULA OFFICINALIS (1X) HPUS) (MARIGOLD) ORG. SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
DIRECTIONS: APPLY TO CLEAN SKIN AFTER EACH DIAPER CHANGE OR AS DIRECTED BY YOUR PHYSICIAN. MAY ALSO BE USED AS A DAILY SKIN PROTECTANT.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS: ORG. OLIVE OIL, ORG. BEESWAX, MILD PROPRIETARY BLEND OF PINE AND FIR EXTRACTS, ORG. COCOA BUTTER, ORG. MILK THISTLE, ORG. ST. JOHN'S WORT, ORG. ALOE VERA GEL, ORG. NON-GMO VITAMIN E

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH DIAPER RASH AND MINOR SKIN IRRITATIONS. SOOTHES SKINS AND PROTECTS AGAINST MOISTURE TP PROMOTE HEALING.

Purpose

Information about the drug product’s indications for use.
PURPOSE SOOTHES RASH, IRRITATION REMEDY FOR SWELLING

Spl product data elements

Usually a list of ingredients in a drug product.
BABY DIAPER RASH CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER OLIVE OIL YELLOW WAX CANADA BALSAM COCOA BUTTER SILYBUM MARIANUM SEED ST. JOHN'S WORT ALOE VERA LEAF .ALPHA.-TOCOPHEROL CALENDULA OFFICINALIS FLOWER CALENDULA OFFICINALIS FLOWER SAMBUCUS NIGRA FLOWER SAMBUCUS NIGRA FLOWER

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
1oz_BabyDiaperRash

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
KEEP ALL DRUGS OUT OF REACH OF CHILDREN.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
CUSTOMER SERVICE 818-851-9014

Storage and handling

Information about safe storage and handling of the drug product.
STORE IN A COOL DRY PLACE OR REFRIGERATE.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
WARNINGS: DO NOT USE IF ALLERGIC TO OR SENSITIVE TO ANY INGREDIENT IN THIS SALVE. TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN BEFORE USE. IF CONDITION PERSISTS OR WORSENS AFTER 3 DAYS SEE A DOCTOR. AVOID DIRECT CONTACT WITH EYES. USE ONLY AS DIRECTED. KEEP ALL DRUGS OUT OF USE OF CHILDREN. SAFE TO USE FOR ALL AGES.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API