OKEEFFES WORKING HANDS PAIN RELIEF SKIN PROTECTANT- allantoin, lidocaine hydrochloride cream

OKeeffes Working Hands Pain Relief by

Drug Labeling and Warnings

OKeeffes Working Hands Pain Relief by is a Otc medication manufactured, distributed, or labeled by The Gorilla Glue Company/O'Keeffe's Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients . . . . . . . . . . . . . Purposes

Allantoin 0.5% . . . . . . . . . . . . . . . . Skin protectant

Lidocaine HCl 4% . . . . . . . . . . . . . Topical analgesic

PURPOSE

Purposes

Uses

temporarily

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

Warnings

For external use only

Do not use

• in large quantities, particularly over raw surfaces or blistered areas.
• on deep or puncture wounds, animal bites or serious burns

When using this product avoid contact with eyes

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

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

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

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

OKEEFFES WORKING HANDS PAIN RELIEF  SKIN PROTECTANT
allantoin, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71564-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
PEPPERMINT OIL (UNII: AV092KU4JH)
SHEA BUTTER (UNII: K49155WL9Y)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
LAURETH-12 (UNII: OAH19558U1)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DODECAMETHYLPENTASILOXANE (UNII: 0QDQ2VQ5YJ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
WHITE WAX (UNII: 7G1J5DA97F)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71564-009-03	1 in 1 CARTON	10/07/2023
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/07/2023

Labeler - The Gorilla Glue Company/O'Keeffe's Company (004251914)