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  5. Label Information: Anti-itch

FDA Label for Anti-itch

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. INACTIVE INGREDIENT
    11. OTHER
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anti-itch Product Label

The following document was submitted to the FDA by the labeler of this product Dolgencorp, 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.

Otc - Active Ingredient



Active ingredients

Menthol 1%

Pramoxine hydrochloride 1%


Otc - Purpose



Purpose

Anti-itch, Pain relief


Indications & Usage



Uses

for temporary relief of pain and itching associated with:

  • minor skin irritations
  • minor cuts
  • minor burns
  • rashes due to poison ivy, poison oak or poison sumac
  • scrapes
  • insect bites

Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use on

  • deep or puncture wounds
  • animals bites
  • serious burns
  • large areas of the body

Otc - When Using



When using this product

  • do not get into eyes or nose
  • not for prolonged use

Otc - Stop Use



Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • if redness, irritation, swelling or pain persists or increases

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.


Dosage & Administration



Directions

adults and children 2 years and older: apply to affected area up to 3 or 4 times daily

children under 2 years: consult a doctor


Inactive Ingredient



Inactive ingredients

aloe vera (aloe barbadensis) leaf juice, diazolidinyl urea, disodium EDTA, eucalyptol, iodopropynyl butylcarbamate, methyl salicylate, mineral oil (parraffinum liquidum), petrolatum, PPG-1 trideceth-6, propylene glycol, sodium acrylates copolymer, steareth-21, stearyl alcohol, thymol,   tocopheryl acetate (vitamin E), triethanolamine, water


Other



Other information

  • store at room temperature
  • for lot no. and exp. date, see crimp of tube or see box

Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL

ANTI-ITCH CREAM

NET WT 1 OZ (28 g)

label of anti-itch - anti itch

label of anti-itch - anti itch


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