Active Ingredient
Pramoxine Hydrochloride 1% (w/w)
Pramoxine Hydrochloride 1% (w/w)
Vagisil Anti-itch Medicated Wipes Maximum Strength Cloth
FDA Label NDC 11509-5035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Combe Incorporated for the product Vagisil Anti-itch Medicated Wipes Maximum Strength (NDC 11509-5035). 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 and ask doctor if, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
External analgesic
Use
Temporarily relieves itching
Temporarily relieves itching
Warnings
For external use only
Avoid contact with eyes
For external use only
Avoid contact with eyes
Stop Use And Ask Doctor If
condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days
condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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 pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily. |
| children under 12 years | consult a doctor |
| adults and children 12 years and older | Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily. |
| children under 12 years | consult a doctor |
Inactive Ingredients
water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin
water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin
Other Information
Store at room temperature
Discard within 2 months of opening
Principal Display Panel
Maximum Strength
Vagisil®
Anti-Itch Medicated Wipes
Instant Relief From Intense Itch
Gynocologist Tested
Clinically Tested
Triple-Action Itch Relief
Wipes Away Intense Itch On Contact
Soothes and Cleanses Skin
Patented Odor Block Technology
12 individually wrapped disposable wipes
5 in. x 7.28 in. (12.7 cm x 18.5 cm)
Maximum Strengthvagisil®anti-itch Medicated Wipesinstant Relief From Intense Itchgynocologist Testedclinically Testedtriple-action Itch Reliefwipes Away Intense Itch On Contactsoothes And Cleanses Skinpatented Odor Block Technology12 Individually Wrapped Disposable Wipes5 In. X 7.28 In. (12.7 Cm X 18.5 Cm) (Vagisil Anti Itch Medicated Wipes Maximum Strength 01)
Vagisil®
Maximum Strength
Anti-Itch Medicated Wipes
Clinically Tested
Instant Relief From Intense Itch
Triple-Action Relief
Wipes Away Intense Itch On Contact
20 soft, disposable wipes
5 in. x 7.28 in. (12.7 cm x 18.5 cm)
Vagisil®maximum Strengthanti-itch Medicated Wipesclinically Testedinstant Relief From Intense Itchtriple-action Reliefwipes Away Intense Itch On Contact20 Soft, Disposable Wipes5 In. X 7.28 In. (12.7 Cm X 18.5 Cm) (Vagisil Anti Itch Medicated Wipes Maximum Strength 02)
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