FDA Label for Family Wellness Cold And Hot Pain Relief

View Indications, Usage & Precautions

Family Wellness Cold And Hot Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Family Dollar. 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 ingredient                                                               Purpose

Menthol 5% .....................................................................Topical analgesic


Otc - Purpose



Uses temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps

Warnings



Warnings

For external use only


Otc - When Using



When using this product:

  • use only as directed
  • do not bandage tightly or use with heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Otc - Stop Use



Stop use and ask a doctor if:

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.  Do not use on infants.  If swallowed, get medical help or contact a Poison Control Center immediately


Indications & Usage



Directions

adults and children over 12 years:

  • carefully remove backing from patch
  • apply sticky side of patch to affected area
    • repeat as necessary, but no more than 4 times daily
    • children 12 years of younger:
      • ask a doctor

Inactive Ingredient



Inactive ingredients: Aloe Barbadensis Leaf Juice, Aluminum Hydroxide, Disodium EDTA, Gelatin, Kaolin, Methylparaben, Glycerin, Titanium Dioxide, Isopropyl Myristate, Purified Water,

Polyvinyl Pyrrolidone, Peg-4 Stearate, Polyvinyl Alcohol, Polysorbate 80, PVP, Tocopherol Acetate, Alumino Magnesium Metasilicate, Castor Oil, Tartaric Acid, BHT, Sodium Polyacrylate.


Dosage & Administration



DISTRIBUTED BY:

FAMILY DOLLAR SERVICES, INC.

10401 MONROE RD.,

MATTHEWS, NC 28105 USA

MADE IN KOREA


Package Label.Principal Display Panel




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