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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