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| Product NDC Code | 11509-5035 | ||||
|---|---|---|---|---|---|
| Drug Name | Vagisil anti-itch medicated wipes maximum strength |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CLOTH | ||||
| RxCUI drug identifier | 1039541, 1039550 |
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| Application Number | part348 | ||||
| Labeler Name | Combe Incorporated | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Pramoxine hydrochloride 1% (w/w)
Active ingredient Pramoxine hydrochloride 1% (w/w)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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. Do not flush. children under 12 years consult a doctor
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. Do not flush. 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. Do not flush. |
| 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. Do not flush. |
| children under 12 years | consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use temporarily relieves itching
Use Temporarily relieves itching
Purpose
Information about the drug product’s indications for use.Purpose External analgesic
Purpose External analgesic
Spl product data elements
Usually a list of ingredients in a drug product.VAGISIL Anti-Itch Medicated Wipes Maximum Strength pramoxine hydrochloride PRAMOXINE HYDROCHLORIDE PRAMOXINE WATER POLYSORBATE 20 GLYCERIN PHENOXYETHANOL DISODIUM COCOAMPHODIACETATE TRIETHANOLAMINE COCOYL GLUTAMATE ETHYLPARABEN EDETATE DISODIUM METHYLPARABEN PEG-7 GLYCERYL COCOATE ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE, DL- MALTODEXTRIN VAGISIL Anti-Itch Medicated Wipes Maximum Strength pramoxine hydrochloride PRAMOXINE HYDROCHLORIDE PRAMOXINE WATER POLYSORBATE 20 GLYCERIN PHENOXYETHANOL DISODIUM COCOAMPHODIACETATE TRIETHANOLAMINE COCOYL GLUTAMATE ETHYLPARABEN EDETATE DISODIUM METHYLPARABEN PEG-7 GLYCERYL COCOATE ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE, DL- MALTODEXTRIN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel Maximum Strength Vagisil ® Medicated Anti-Itch Wipes Instant Relief From Intense Itch Gynecologist Tested Clinically Tested On-the-go relief With Aloe & Vitamin E Patented Odor Block Technology 12 individually wrapped disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm) Maximum Strength Vagisil® Medicated Anti-Itch Wipes Instant Relief From Intense Itch Gynecologist Tested Clinically Tested • On-the-go relief • With Aloe & Vitamin E • Patented Odor Block Technology 12 individually wrapped disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm)
Principal Display Panel Vagisil ® Maximum Strength Medicated Anti-Itc h Wipes Gynecologist Tested Instant Relief From Intense Itch With Aloe & Vitamin E Patented Odor Block Technology 20 soft, disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm) Principal Display Panel Vagisil® Maximum Strength Medicated Anti-Itch Wipes Gynecologist Tested Instant Relief From Intense Itch • With Aloe & Vitamin E • Patented Odor Block Technology 20 soft, disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm) Vagisil® Maximum Strength Medicated Anti-Itch Wipes Gynecologist Tested Instant Relief From Intense Itch • With Aloe & Vitamin E • Patented Odor Block Technology 20 soft, disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm)
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.VAGISIL Anti-Itch Medicated Wipes Drug Facts
VAGISIL Maximum Strength Medicated Anti-Itch W ipes Drug Facts
Other information store at room temperature discard within 2 months of opening
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
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
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only Avoid contact with eyes
Warnings For external use only Avoid contact with eyes
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API