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OKeeffesCompany.com
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O'Keeffe's Company
Cincinnati, OH 45241
Made in USA with Domestic and Imported Materials
Okeeffes Skin Repair Cream
FDA Label NDC 71564-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Gorilla Glue Company/o'keeffe's Company for the product Okeeffes Skin Repair (NDC 71564-010). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Colloidal oatmeal 2%
Otc - Purpose
Purpose
Skin protectant
Indications & Usage
Uses
temporarily protects and helps relieve minor skin irritation and itching due to:
- rashes
- eczema
- poison ivy, oak, or sumac
- insect bites
Warnings
Warnings
For external use only
Otc - When Using
When using this product do not get into eyes
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens
- symptoms last more than 7 days or clear up and 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
apply as needed
Inactive Ingredient
Inactive ingredients Water, Glycerin, Cetyl Alcohol, Isopropyl Myristate, Dimethicone, Aluminum Starch Octenylsuccinate, Cetearyl Alcohol, Polysilicone-11, Ceteareth-20, Butyrospermum Parkii (Shea) Butter, Distearyldimonium Chloride, 1,2-Hexanediol, Allantoin, Caprylyl Glycol, Glyceryl Stearate, PEG-100 Stearate, Caesalpinia Spinosa Gum, Panthenol, Polyquaternium-10, Beeswax, Bisabolol, Disodium EDTA, Laureth-12, Phenoxyethanol, Laureth-23, Laureth-4, Ethylhexylglycerin, Zingiber Offcinale Root Extract
Package Label.Principal Display Panel
O'KEEFFE'S®
SKIN REPAIR BODY CREAM
ECZEMA RELIEF
48 HOUR ITCH RELIEF IN ONE USE
Colloidal Oatmeal Skin Protectant
Dermatologist Approved
ACCEPTED National Eczema Association
Steroid & Fragrance Free
GUARANTEED RELIEF
Net Wt. 7 oz. (198 g)
* Please review the disclaimer below.
