FDA Label for Quality Choice Anti Itch With Aloe

View Indications, Usage & Precautions

Quality Choice Anti Itch With Aloe Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association 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 ingredient                                                         Purpose

Hydrocortisone 1%................................................... Anti-itch


Otc - Purpose



Uses

  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis
  • for temporary relief of external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor

Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use

  • in the genital area if you have a vaginal discharge. Consult a doctor
  • for the treatment of diaper rash. Consult a doctor

Otc - When Using



When using this product

  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

Otc - Stop Use



Stop use and ask a doctor if

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor
  • rectal bleeding occurs

Otc - Keep Out Of Reach Of Children



Keep out of reach of children

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


Indications & Usage



Directions

  • for itching of skin irritation, inflammation, and rashes:
  • 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: consult a doctor
  • for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor

Storage And Handling



Other information

  • store at 20°-25°C (68°-77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredient



Inactive ingredients

aloe vera gel, butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, polyoxyethylene cetyether, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol


Dosage & Administration



DISTRIBUTED BY C.D.M.A., INC.

43157 W. NINE MILE

NOVI, MI 48376-0995

www.qualitychoice.com

MADE IN KOREA


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