O"keeffe's Healthy Feet Pain Relief

O"keeffe's Healthy Feet Pain Relief
SPL v2
SPL
SPL Set ID d73709db-3932-3c56-e053-2995a90a7d0a
Route
TOPICAL
Published
Effective Date 2022-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.5 g)
Inactive Ingredients
Peppermint Oil Phenoxyethanol Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Shea Butter Sodium Hydroxide Water Xanthan Gum Edetate Disodium Anhydrous Ethylhexylglycerin Glycerin 1,2-hexanediol Isopropyl Myristate White Wax Caprylyl Glycol Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Cetyl Alcohol Dodecamethylpentasiloxane Glyceryl 1-stearate Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) Aluminum Starch Octenylsuccinate Laureth-12 Peg-100 Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses temporarily

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

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

Child-resistant packaging. Store with lid closed tightly.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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
Section 50567-7

When using this product avoid contact with eyes

Section 50570-1

Do not use

  • in large quantities, particularly over raw surfaces or blistered areas.
  • on deep or puncture wounds, animal bites or serious burns
Section 51727-6

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

Section 51945-4

O'KEEFFE'S

FOR HEALTHY FEET

PAIN RELIEF CREAM

SKIN PROTECTANT

PAIN RELIEF

RELIEVES, SOOTHES & HYDRATES

INSTANT RELIEF from:

Pain

Itching

Irritation

Dryness

GUARANTEED RELIEF

2 IN 1 PAIN RELIEF & MOISTURIZER

PODIATRIST APPROVED

MAX STRENGTH 4% LIDOCAINE

COOLING PEPPERMINT OIL

Net Wt. 3 oz. (85 g)

Section 53413-1

Questions or comments?

1-800-275-2718

Section 53414-9

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

Section 55105-1

Purposes

Skin protectant

Topical analgesic

Section 55106-9

Active ingredients

Allantoin 0.5%

Lidodaine HCl 4%


Structured Label Content

Indications and Usage (34067-9)

Uses temporarily

  • relieves pain and itching associated with minor skin irritations
  • protects and helps relieve chapped or cracked skin
Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

Child-resistant packaging. Store with lid closed tightly.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 50570-1 (50570-1)

Do not use

  • in large quantities, particularly over raw surfaces or blistered areas.
  • on deep or puncture wounds, animal bites or serious burns
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

O'KEEFFE'S

FOR HEALTHY FEET

PAIN RELIEF CREAM

SKIN PROTECTANT

PAIN RELIEF

RELIEVES, SOOTHES & HYDRATES

INSTANT RELIEF from:

Pain

Itching

Irritation

Dryness

GUARANTEED RELIEF

2 IN 1 PAIN RELIEF & MOISTURIZER

PODIATRIST APPROVED

MAX STRENGTH 4% LIDOCAINE

COOLING PEPPERMINT OIL

Net Wt. 3 oz. (85 g)

Section 53413-1 (53413-1)

Questions or comments?

1-800-275-2718

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Skin protectant

Topical analgesic

Section 55106-9 (55106-9)

Active ingredients

Allantoin 0.5%

Lidodaine HCl 4%


Advanced Ingredient Data


Raw Label Data

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