FDA Label for Okeeffes Healthy Feet Pain Relief Cream

View Indications, Usage & Precautions

Okeeffes Healthy Feet Pain Relief Cream Product Label

The following document was submitted to the FDA by the labeler of this product Raining Rose, Inc.. 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.

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Drug Facts


Otc - Active Ingredient



Active ingredients
Allantoin 0.5%
Lidocaine HCI 4%


Otc - Purpose



Purposes
Allantoin 0.5%  .........Skin protectant
Lidocaine HCI4%  ....Topical analgesic


Indications & Usage



Uses temporarily
• relieves pain and itching associated with minor
  skin irritations
• protects and helps relieve chapped or cracked
  skin


Warnings



Warnings
For external use only

Do not use
• in large quantilies, particularly over raw
  surfaces or blistered areas.
• on deep or puncture wounds, animal biles or
  serious burns

When using this product avoid conlacl with eyes

Stop use and ask a doctor if
• condilion worsens
• symploms last more Ihan 7days or clear up
  and occur again wilhin afew days


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed,
get medical help or contact a Poison Control
Center righl away.


Dosage & Administration



Directions
• adults and children 12 years of age and older:
   Apply to affected area not more than 3 to 4
   times daily.
• children under 12 years of age: consult a doclor.


Other Safety Information



Other information Child-resistant packaging.
Store with lid closed tightly.


Inactive Ingredient



Inactive ingredients Acrylates/C10-30 Alkyl
Acrylate Crosspolymer, Aluminum Starch
Octenylsuccinate, Beeswax, Caprylyl Glycol,
Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol,
Dimelhicone, Disodium EDTA, Ethylhexylglycerin,
Glycerin, Glyceryl Stearate, 1,2 Hexanediol,
Isopropyl Myrislate, Laureth-12, PEG-100
Stearate, Peppermint (Mentha Piperita) Oil,
Phenoxyethanol, Polysilicone-11, Shea
(Butyrospermum Parkii) Butter, Sodium
Hydroxide, Water, Xanthan Gum


Principal Display Package



O'KEEFFE'S

FOR HEALTHY FEET

Net Wt. 3 oz. (85 g)

Distributed by:

O'Keeffe's Company, Cincinnati, OH 45241

Questions/Comments: 1-800-275-2718

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