Family Wellness Cream
FDA Label NDC 69571-005

10 label sections · Submitted to the FDA by Front Pharmaceutical Plc · 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

for temprary relief from pain and itching associated Uses

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

•avoid contact with eyes When using this product

Ask a doctor before use

•on chicken pox  •on measles

Stop use and ask a doctor if

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

. If swallowed, get medical help Keep out of reach of children

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

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

(15° - 30° C).

Inactive Ingredient

cetyl alcohol, glyceryl stearate se, Inactive ingredients

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

glycol, propylparaben, stearic acid, stearic alcohol, water

Otc - Questions

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

Label

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