FDA Label for Family Care Anti-itch

View Indications, Usage & Precautions

Family Care Anti-itch Product Label

The following document was submitted to the FDA by the labeler of this product Tai Guk Pharm. Co., Ltd.. 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                                                                                  Purpose

Diphenhydramine Hydrochloride USP, 1%................................................Antihistamine

Zinc acetate, 0.1%.................................................................................Skin Protectant


Otc - Purpose



Uses

  • for the temporary relief of itching and pain associated with minor skin irritations and rashes due to insect bites, poison ivy, poison oak, poison sumac
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings



For external use only


Otc - Do Not Use



Do not use

  • on chicken pox, measles, blisters or on extensive areas of the skin
  • any other drug containing diphenhydramine while using this product

Otc - When Using



When using this product avoid contact with the eyes


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


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

  • adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily, or as directed by a doctor
  • children under 12 years of age, consult a doctor
  • do not use with any other product containing diphenhydramine, even one taken by mouth
  • discontinue use and consult a physician if rash or irritation develops

Safe Handling Warning



Other information

  • store at room temperature
  • Lot No. and Exp. Date: see box or see crimp of tube

Inactive Ingredient



Inactive ingredients

Propylene Glycol, Cetanol, Polyoxyl 40 Stearate, Stearyl Alcohol, Methylparaben, Propylparaben, Purified Water


Dosage & Administration



Distributed by:

Consumer Care Products Corp.

Cerritos, CA 90703   USA


Package Label.Principal Display Panel



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