OKEEFFES HEALTHY FEET PAIN RELIEF CREAM- pain relief cream lotion

OKeeffes Healthy Feet Pain Relief Cream by

Drug Labeling and Warnings

OKeeffes Healthy Feet Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by Raining Rose, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients
Allantoin 0.5%
Lidocaine HCI 4%

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

PREGNANCY OR BREAST FEEDING

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

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

Carton

Tube

res

INGREDIENTS AND APPEARANCE

OKEEFFES HEALTHY FEET PAIN RELIEF CREAM 
pain relief cream lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0311
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	4.0 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0311-1	1 in 1 CARTON	03/01/2022
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	03/01/2022

Labeler - Raining Rose, Inc. (083819404)

Registrant - Raining Rose, Inc. (083819404)