Active Ingredient Purpose

Manufacturer
Rida LLC
Effective date
2026-06-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-11 05:11:24

Label at a glance#

ProductTerramed Just Think Comfort GynoCare BV Guard Intimate Wash
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure7 sections

Indications and 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

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient                                                              Purpose

OTC - ACTIVE INGREDIENT SECTION

Pramoxine Hydrochloride 1% (w/w) Anti-itch                       External analgesic

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83004-04083004-040-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terramed Just Think Comfort GynoCare BV Guard Intimate WashPRAMOXINE HYDROCHLORIDERida LLC09964550-049c-4c3b-817d-37e660c2e45c2026-06-08WarningsExact identifier
ndc (package): 83004-040-01
ndc (product): 83004-040
ndc11 (package): 83004004001
spl id: 53c13065-d6a0-9bb5-e063-6294a90ac630
spl set id: 09964550-049c-4c3b-817d-37e660c2e45c

Reported adverse events (FAERS/openFDA)#

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