FDA Label for Vagisil Anti-itch Medicated Wipes Maximum Strength

View Indications, Usage & Precautions

Vagisil Anti-itch Medicated Wipes Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Combe Incorporated. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Pramoxine Hydrochloride 1% (w/w)

Pramoxine Hydrochloride 1% (w/w)


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 yearsconsult 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 yearsconsult 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)

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)


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