Otc - Active Ingredient
Active ingredients . . . . . . . . . . . . . Purposes
Allantoin 0.5% . . . . . . . . . . . . . . . . Skin protectant
Lidocaine HCl 4% . . . . . . . . . . . . . Topical analgesic
Okeeffes Working Hands Pain Relief Cream
FDA Label NDC 71564-009
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 Working Hands Pain Relief (NDC 71564-009). 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 otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
temporarily
- relieves pain and itching associated with minor skin irritations
- protects and helps relieve chapped or cracked skin
Warnings
For external use only
Otc - Do Not Use
Do not use
- in large quantities, particularly over raw surfaces or blistered areas.
- on deep or puncture wounds, animal bites or serious burns
Otc - When Using
When using this product avoid contact with 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 - 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. If swallowed, get medical help or contact a Poison Control Center right away.
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 doctor.
Other Information
Child-resistant packaging. Store with lid closed tightly.
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aluminum Starch Octenylsuccinate, Beeswax, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, 1,2 Hexanediol, Isopropyl Myristate, Laureth-12, PEG-100 Stearate, Peppermint (Mentha Piperita) Oil, Phenoxyethanol, Polysilicone-11, Shea (Butyrospermum Parkii) Butter, Sodium Hydroxide, Water, Xanthan Gum
Questions Or Comments?
1-800-275-2718
Other
O'KEEFFE'S ® WORKING HANDS ®
PAIN RELIEF CREAM SKIN PROTECTANT
PAIN RELIEF
RELIEVES, SOOTHES & HYDRATES
INSTANT RELIEF from:
Pain
Itching Irritation
Dryness
2 IN 1 PAIN RELIEF & MOISTURIZER
MAX STRENGTH † 4% LIDOCAINE
COOLING PEPPERMINT OIL
CLINICALLY PROVEN
RELIEVES
SOOTHES
HYDRATES
PROTECTS
Package Label.Principal Display Panel
OKEEFFE'S ® WORKING HANDS ®
PAIN RELIEF CREAM SKIN PROTECTANT
Net Wt. 3 oz (85 g)
OKeeffesCompany.com
1-800-275-2718
©2023 Distributed by:
O'Keeffe's Company
Cincinnati, OH 45241
Made in USA with Domestic and Imported Materials
Label (Label)
* Please review the disclaimer below.
