Earth's Care ®

Earth's Care ®
SPL v6
SPL
SPL Set ID e860d65b-126d-4d77-8003-9d1381849ab5
Route
TOPICAL
Published
Effective Date 2022-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (10 g) Menthol, Unspecified Form (0.8 g)
Inactive Ingredients
Water Lanolin Aloe Vera Leaf Cetyl Hydroxyethylcellulose (350000 Mw) Glycerin Shea Butter Almond Oil Glyceryl Monostearate Heptyl Undecylenate Cetyl Alcohol Medium-chain Triglycerides Olive Oil Tocopherol Phenoxyethanol Ethylhexylglycerin Horse Chestnut Calendula Officinalis Flower Chamaemelum Nobile Flower

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-06-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporary relief of pain, itching, burning and discomfort associated with hemorrhoids
  • may provide a cooling sensation
  • can help distract from pain
  • aids in protecting anorectal areas
  • temporary relief of irritation
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 53414-9

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

Section 55105-1
Active ingredients Purpose
Menthol USP 0.8% Analgesic
Witch Hazel USP 10% Astringent
Warnings

For external use only

Questions

1-888-602-6380

Directions

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or drying with a tissue or a soft cloth before applying cream. When first opening the tube, remove cap and lift foil safety seal from tube. Apply externally to the affected area up to 6 times daily.

Children under 12 years of age: consult a doctor.

Allergy Alert
  • Certain persons can develop allergic reactions to ingredients in this product
Inactive Ingredients

aloe vera ( Aloe barbadensis) gel, calendula ( Calendula officinalis) flower extract, chamomile ( Matricaria recutita) flower extract, caprylic/capric triglyceride, cetyl alcohol, cetyl hydroxyethylcellulose, ethylhexylglycerin, glycerin, glyceryl stearate, heptyl undecylenate, horse chestnut ( Aesculus hippocastanum) seed extract, lanolin, olive ( Olea europaea) oil, phenoxyethanol, polyglyceryl-3 dicitrate/stearate, sweet almond ( Prunus amygdalus dulcis) oil, purified water, shea ( Butyrospermum parkii) butter, tocopherols

When Using This Product
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor
  • if the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
  • if bleeding occurs
  • if condition worsens or does not improve within 7 days
Principal Display Panel 28 G Tube Box

No Vasoconstrictors

EARTH'S

CARE

PARABEN

FREE

Hemorrhoid

Relief Cream

Dual-Action Formula

Relieves external

discomfort

with Witch Hazel and

Menthol

1% FOR THE

PLANET

MEMBER

1OZ. (28g)


Structured Label Content

Uses
  • temporary relief of pain, itching, burning and discomfort associated with hemorrhoids
  • may provide a cooling sensation
  • can help distract from pain
  • aids in protecting anorectal areas
  • temporary relief of irritation
Section 42229-5 (42229-5)

Drug Facts

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 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
Menthol USP 0.8% Analgesic
Witch Hazel USP 10% Astringent
Warnings

For external use only

Questions

1-888-602-6380

Directions

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or drying with a tissue or a soft cloth before applying cream. When first opening the tube, remove cap and lift foil safety seal from tube. Apply externally to the affected area up to 6 times daily.

Children under 12 years of age: consult a doctor.

Allergy Alert
  • Certain persons can develop allergic reactions to ingredients in this product
Inactive Ingredients (Inactive ingredients)

aloe vera ( Aloe barbadensis) gel, calendula ( Calendula officinalis) flower extract, chamomile ( Matricaria recutita) flower extract, caprylic/capric triglyceride, cetyl alcohol, cetyl hydroxyethylcellulose, ethylhexylglycerin, glycerin, glyceryl stearate, heptyl undecylenate, horse chestnut ( Aesculus hippocastanum) seed extract, lanolin, olive ( Olea europaea) oil, phenoxyethanol, polyglyceryl-3 dicitrate/stearate, sweet almond ( Prunus amygdalus dulcis) oil, purified water, shea ( Butyrospermum parkii) butter, tocopherols

When Using This Product (When using this product)
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
  • if bleeding occurs
  • if condition worsens or does not improve within 7 days
Principal Display Panel 28 G Tube Box (PRINCIPAL DISPLAY PANEL - 28 g Tube Box)

No Vasoconstrictors

EARTH'S

CARE

PARABEN

FREE

Hemorrhoid

Relief Cream

Dual-Action Formula

Relieves external

discomfort

with Witch Hazel and

Menthol

1% FOR THE

PLANET

MEMBER

1OZ. (28g)


Advanced Ingredient Data


Raw Label Data

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