Active Ingredient Purpose
Pramoxine Hydrochloride 1% (w/w) Anti-itch External analgesic
Terramed Just Think Comfort Gynocare Bv Guard Intimate Wash Liquid
FDA Label NDC 83004-040
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 Terramed Just Think Comfort Gynocare Bv Guard Intimate Wash (NDC 83004-040). 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.
Label Section Quick Index
Uses
For the temporary relief of:
• Pain, itching, and burning associated with minor external vaginal irritation
• Minor skin irritation and discomfort in the external genital area
Warnings
For external use only.
Do not use inside the vagina.
Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
Ask a doctor before use if you are pregnant or breastfeeding.
When using this product:
• Do not apply to open wounds, broken skin, or active rashes.
• Do not apply more than 2 times daily.
• If irritation worsens after use, discontinue immediately.
• Rinse thoroughly after each use — do not leave product on skin.
Stop use and ask a doctor if:
• Symptoms persist for more than 7 days.
• Symptoms clear up and return within a few days.
• You experience unusual vaginal discharge, fever, foul odor, or pelvic pain.
• Symptoms worsen at any time.
• A rash or allergic reaction develops.
Keep out of reach of children.
If swallowed, contact a Poison Control Center immediately at
1-800-222-1222or seek emergency medical assistance
Directions
For adult women 18 years and older:
• Wet external vaginal area with warm water.
• Dispense a small amount of wash into your hands or onto a clean washcloth.
• Gently cleanse the external vaginal area only.
• Allow wash to remain on skin for 30–60 seconds.
• Rinse thoroughly with warm water.
• Pat dry.
• Use once or twice daily.
Other Information
Store at controlled room temperature: 59°F – 86°F (15°C – 30°C).
• Close the cap tightly after each use.
• Protect from freezing and excessive heat.
• Use within 12 months of opening.
Inactive Ingredients
Purified Water, Decyl Glucoside, Cocamidopropyl Betaine, Glycerin, Lactic Acid, Sodium Lactate, Aloe Barbadensis Leaf Juice, Calendula Officinalis Extract, Chamomile Extract, Panthenol (Pro-Vitamin B5), Allantoin, Sodium PCA, Phenoxyethanol, Ethylhexylglycerin, Disodium EDTA, Xanthan Gum. Contains coconut-derived ingredients.
Product Label
Image Description (Image 40)
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