Active Ingredient Purpose
Pramoxine hydrochloride 1% External analgesic
Terramed Just Think Comfort Gynocare Bv Guard Intimate Wipes Cloth
FDA Label NDC 83004-038
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 Wipes (NDC 83004-038). 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
• cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
• relieves itching, burning, cracking, and scaling which accompany these conditions
Warnings
For external use only.
Do not use
• on children under 2 years of age unless directed by a doctor
When using this product
• avoid contact with eyes
• if contact occurs, rinse thoroughly with water
Stop use and ask a doctor if
• irritation occurs
• there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
•
adults and children 2 years and over:
• apply to affected area and lather
• leave on skin for 3–5 minutes, then rinse thoroughly
• use twice daily (morning and night) or as directed by a doctor
• supervise children in the use of this product
•
for athlete's foot, pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
•
for jock itch, use daily for 2 weeks
•
for athlete's foot and ringworm, use daily for 4 weeks
• if condition persists longer, consult a doctor
• this product is not effective on the scalp or nails
•
children under 2 years: ask a doctor
Other Information
• store at 20°–25°C (68°–77°F)
• protect from excessive heat
Inactive Ingredients
Aloe Barbadensis Leaf Juice (Organic), Centella Asiatica Extract, Cocamidopropyl Betaine, Decyl Glucoside, Equisetum Arvense (Horsetail) Extract, Lauramidopropyl Betaine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Menthol, Panthenol, Pelargonium Graveolens (Geranium) Flower Oil (Organic), Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Sodium Hydroxide, Taraxacum Officinale (Dandelion) Extract, Water.
Product Label
Image Description (Image 1)
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