Label: LOLA VAGINAL ITCH RELIEF WIPES- pramoxine hydrochloride cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 81032-422-28 - Packager: Alyk, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 7, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- Stop Use
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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
- Directions
- Other Information
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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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INGREDIENTS AND APPEARANCE
LOLA VAGINAL ITCH RELIEF WIPES
pramoxine hydrochloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81032-422 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) SODIUM BENZOATE (UNII: OJ245FE5EU) TOCOPHEROL (UNII: R0ZB2556P8) APPLE CIDER VINEGAR (UNII: 0UE22Q87VC) WATER (UNII: 059QF0KO0R) OAT BRAN (UNII: KQX236OK4U) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) GLUCONIC ACID (UNII: R4R8J0Q44B) GLYCERIN (UNII: PDC6A3C0OX) LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U) POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885) POLYGLYCERYL-6 CAPRYLATE (UNII: DGV8R54VG7) LEVOMENOL (UNII: 24WE03BX2T) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81032-422-28 28 in 1 POUCH; Type 0: Not a Combination Product 03/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/31/2021 Labeler - Alyk, Inc. (079830975)
