FDA Label for Family Wellness

View Indications, Usage & Precautions

Family Wellness Product Label

The following document was submitted to the FDA by the labeler of this product Front Pharmaceutical Plc. 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

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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