Active Ingredient
Pramoxine hydrochloride 1% (w/w)
Lola Vaginal Itch Relief Wipes
FDA Label NDC 81032-422
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alyk, Inc. for the product Lola Vaginal Itch Relief Wipes (NDC 81032-422). 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, use, warnings, stop use, do not use, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Use
Temporarily relieves itching
Warnings
For external use only
Avoid contact with eyes
Stop Use
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.
Do Not Use
- Skin: This product is expected to contact with skin. If irritation is experienced, discontinue use of product. If discomfort persists, seek medical attention.
- Eye: Hold eyelid open and flush with water for at least 15 minutes. If irritation persists, seek medical attention.
- Ingestion: Wipes may present a choking hazard. Accidental ingestion may necessitate medical attention.
- Inhalation: Not likely to be inhaled. If symptomatic, remove to fresh air.
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years and older. Unfold towelette and gently wipe external vaginal area. Use each towelette only once and then throw away. Use no more than 3 to 4 times daily.
Other Information
Use according to package label instructions. Keep in cool storage.
Inactive Ingredient(S)
Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Bran Extract, Bisabolol, Citric Acid, Decyl Glucoside, Gluconic Acid, Glycerin, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Polyglyceryl-4 Caprate, Polyglyceryl-6 Caprylate, Saccharomyces Ferment Filtrate, Sodium Benzoate, Tetrasodium Glutamate Diacetate, Tocopherol, Vinegar (Apple Cider), Water
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