Active Ingredient
Hydrocortisone Acetate, 1%
Vagisil Anti-itch Creme Maximum Strength Sensitive Skin Formula Cream
FDA Label NDC 11509-5101
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 Creme Maximum Strength Sensitive Skin Formula (NDC 11509-5101). 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 a doctor if, do not use if, 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
Anti-itch
Use
For temporary external feminine itching
Warnings
For External Use Only
Avoid Contact with eyes
Stop Use And Ask A Doctor If
condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again in a few days.
Do Not Use If
you have a vaginal discharge. Consult a physician.
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 | Apply to external vaginal area not more than 3 to 4 times a day |
| Children under 12 years | Consult a doctor |
Inactive Ingredients:
water, cetyl ethylhexanoate, glycerin , PEG-40 hydrogenated castor oil , glyceryl dilaurate, dimethicone, colloidal oatmeal, aloe barbadensis leaf extract, sodium polyacrylate, caprylyl glycol ,ceteareth-20, glyceryl oleate , acrylates/C10-30 alkyl acrylate crosspolymer, cyclopentasiloxane, trideceth-6, sodium hydroxide, disodium EDTA, sorbic acid, PEG/PPG-18/18 dimethicone, tocopheryl acetate, maltodextrin, phenoxyethanol
Principal Display Panel
Vagisil Anti-Itch Crème Maximum Strength, Sensitive Skin Formula, 1% Hydrocortisone
1 oz (28 g)
Vagisil Anti-itch Crème Maximum Strength, Sensitive Skin Formula, 1% Hydrocortisone1 Oz (28 G) (Vagisil Anti Itch Creme Maximum Strength Sensitive 01)
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