FDA Label for Ivarest Poison Ivy Removal And Itch Relief

View Indications, Usage & Precautions

Ivarest Poison Ivy Removal And Itch Relief Product Label

The following document was submitted to the FDA by the labeler of this product Blistex Inc.. 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.

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Drug Facts


Active Ingredient



Pramoxine HCl 1.0% (w/w)


Purpose



External analgesic


Uses



  • for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac

Warnings



For external use only


When Using This Product



  • avoid contact with the eyes
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Directions



  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: do not use, consult a doctor.

Other Information



  • To remove urushiol plant oils from the skin:
    • apply pad and wipe across affected area in one direction
    • repeat the above step using a second pad
    • DO NOT FLUSH – after application, discard pads in trash and wash hands
    • Do not use if seal is broken
    • www.ivarest.com


Inactive Ingredients



aloe barbadensis leaf juice, ammonium xylenesulfonate, avena sativa (oat) kernel extract, citric acid, decyl glucoside, ethylhexylglycerin, glycerin, hamamelis virginiana (witch hazel) water, phenoxyethanol, polysorbate 60, purified water, SD alcohol 38-B, simethicone, sodium hydroxide, tetrasodium EDTA


Principal Display Panel - 30 Pad Jar Carton



IVAREST®

NEW

MAXIMUM STRENGTH

+
POISON IVY
OIL REMOVAL &
ITCH RELIEF PADS
External Analgesic

REMOVES MORE THAN 99% OF URUSHIOL OILS*

IMMEDIATELY CLEANSES & CALMS SKIN

INSTANT ITCH & PAIN RELIEF
FROM OUTDOOR ITCHES

+
DOCTOR
RECOMMENDED

30
PADS


* Please review the disclaimer below.