Medicated Foaming Feminine Gel
FDA Label NDC 83004-015

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rida Llc for the product Medicated Foaming Feminine (NDC 83004-015). 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 active ingredient                                                          purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient                                                          Purpose

● Lactic Acid 0.5%:                                 Maintains natural pH levels, fostering a healthy environment to prevent irritation and infections.


● Boric Acid 0.5%:                                  Restores and stabilizes acidic pH levels, effectively preventing yeast infections.


● Chlorhexidine Digluconate 1%:       Offers potent antibacterial protection, reducing the risk of bacterial infections without disrupting the vaginal flora.     


● Cnidium Monnieri Fruit Extract 0.5%:    Provides anti-inflammatory properties, soothing the skin and reducing any potential irritation.


● Bisabolol 0.3%:                                  Calms and soothes the skin, reducing redness and providing a gentle, comforting effect upon application.

Uses

● Antimicrobial action: Effectively targets and eliminates harmful bacteria to maintain natural balance.
● UTI Defense: Actively helps to prevent urinary tract infections.
● Odor Control: Neutralizes odors, leaving you feeling fresh and clean.

Warnings

For external use only.

Do not use:
○ On broken or punctured wounds.
○ On animal bites.
○ On serious burns.

When using this product:
○ Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
○ Do not apply large amounts to the body.


Stop use and ask a doctor if:
○ Irritation or redness develops.
○ Condition worsens or does not improve within 7 days.

Directions

● Wet the area: Begin by splashing water on the external vaginal area or take this step while in the shower or bath to ensure the area is moist.
● Apply the wash: Pump a small amount of the foam onto your hand. The foam should be rich and airy. Typically, two pumps are sufficient.
● Gentle Cleansing: Gently apply foam to the delicate areas. Use your hand to spread the foam, covering the entire area with gentle, circular motions. Avoid using sponges or washcloths, as they can be too abrasive.
● Rinse thoroughly: After cleansing, rinse thoroughly with warm water. Ensure all traces of the wash are removed to avoid irritation.
● Pat dry: Gently pat the area with a clean towel. Avoid rubbing, as this may cause irritation. It's important to ensure the area is completely dry before dressing to prevent moisture buildup, which can lead to irritation or infections.

Other Information

● Lot number and expiration date: See packaging for details.
● Keep out of reach of children. If swallowed, call a poison control center right away.
● Store at room temperature. Keep the bottle tightly closed. Avoid direct sunlight and excessive heat to maintain product integrity.

Inactive Ingredients

Water (Aqua), Glycerin, Cocamidopropyl Betaine, Sodium Lauryl Glucose Carboxylate, Lauryl Glucoside, Xanthan Gum, Sodium Benzoate
Citric Acid, Allantoin, Panthenol, Aloe Barbadensis Leaf Juice, Tocopherol (Vitamin E), Ethylhexylglycerin

Product Label

Image Description (Gylabel)

Image Description (Gylabel)

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