LOLA VAGINAL ITCH RELIEF WIPES- pramoxine hydrochloride cloth 
Alyk, Inc.

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.

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Active Ingredient

Pramoxine hydrochloride 1% (w/w)

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

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

Principal Display Panel

28ct in 1 pouch NDC 81032-422-28

LOLA VAGINAL ITCH RELIEF WIPES 
pramoxine hydrochloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81032-422
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81032-422-2828 in 1 POUCH; Type 0: Not a Combination Product03/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/31/2021
Labeler - Alyk, Inc. (079830975)

Revised: 4/2021
Document Id: bf671909-2956-10ba-e053-2995a90a50d4
Set id: be77387d-5f48-4592-e053-2a95a90a384d
Version: 2
Effective Time: 20210407
 
Alyk, Inc.