Family Care Anti-itch
FDA Label NDC 68169-0049

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tai Guk Pharm. Co., Ltd. for the product Family Care Anti-itch (NDC 68169-0049). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Image Of Carton Label (Fcantiitch)

Image Of Carton Label (Fcantiitch)

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