Label: CALAMINE- zinc oxide, ferric oxide red, pramozine hcl lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 6, 2013

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  • Active ingredients
    Calamine 8% Pramoxine HCl 1%
  • Purpose
    Skin protectant - Topical analgesic
  • Uses
    temporarily relieves pain and itching associated with: rashes due to poison ivy, poison oac or poison sumac - insect bites - minor skin irritation - minor cuts - dries the oozing and weeping of poison ...
  • Warnings
    For external use only. When using this product - do not get into eyes - Stop use and ask a doctor if - condition worsens or does not improve within 7 days - symptoms persist for more than 7 days ...
  • Directions
    shake well before use - 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: ask a doctor
  • Other information
    store at 20° to 25°C (68° to 77°F)
  • Inactive ingredients
    SD alcohol 38-B, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, zanthan gum
  • Package Label
    image of bottle label
  • INGREDIENTS AND APPEARANCE
    Product Information