Family Wellness Cream
FDA Label NDC 69571-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Front Pharmaceutical Plc for the product Family Wellness (NDC 69571-005). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, 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

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Otc - Purpose

Purpose

Topical analgesic

Skin protectant

Indications & Usage

Uses for temprary relief from pain and itching associated

with insect bites , sunburn and mior skin irritations. Dries the

oozing and weeping of poison: •ivy  •oak  •sumac

Warnings

Warnings

For external use only.

Do not use

  • over large areas of the body
  • with any other product containing diphenhydramine including those taken orally

    • When using this product •avoid contact with eyes

    Ask a doctor before use

    •on chicken pox  •on measles

    Stop use and ask a doctor if

    • symptoms last for more than 7 days
    • the condition gets worse
    • symptoms clear up and then 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.

Dosage & Administration

Directions

•for adults and children over 2 years of age: apply to affected

area not more than 3 to 4 times daily

•children under 2 years of age: ask a doctor before use

Other Safety Information

Other information store at room temperature 59° - 86° F

(15° - 30° C).

Inactive Ingredient

Inactive ingredients cetyl alcohol, glyceryl stearate se,

laureth-23, methylparaben, mineral oil, petrolatum, propylene

glycol, propylparaben, stearic acid, stearic alcohol, water

Otc - Questions

Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST

Label

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