EARTHS CARE HEMORRHOID RELIEF- witch hazel and menthol, unspecified form cream

Earths Care Hemorrhoid Relief by

Drug Labeling and Warnings

Earths Care Hemorrhoid Relief by is a Otc medication manufactured, distributed, or labeled by DLC Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Menthol USP 0.8%	Analgesic
Witch Hazel USP 10%	Astringent

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

Warnings

For external use only

Allergy Alert

• Certain persons can develop allergic reactions to ingredients in 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

• 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

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: 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.

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

Questions

1-888-602-6380

SPL UNCLASSIFIED SECTION

Distributed by:
Earth's Care Natural Products, Inc.
Long Beach, California 90805 USA

PRINCIPAL DISPLAY PANEL - 28 g Tube Box

No Vasoconstrictors

EARTH'S
CARE®

New

Hemorrhoid
Relief Cream

Dual-Action formula

Relieves external
discomfort

with Witch Hazel and
Menthol

1%
FOR THE
PLANET®
MEMBER

1 OZ. (28 g)

INGREDIENTS AND APPEARANCE

EARTHS CARE HEMORRHOID RELIEF 
witch hazel and menthol, unspecified form cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24286-1570
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34)	Witch Hazel	10 g  in 100 g
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	0.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Lanolin (UNII: 7EV65EAW6H)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Cetyl Hydroxyethylcellulose (350000 MW) (UNII: T7SWE4S2TT)
Glycerin (UNII: PDC6A3C0OX)
Shea Butter (UNII: K49155WL9Y)
Almond Oil (UNII: 66YXD4DKO9)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Heptyl Undecylenate (UNII: W77QUB6GXO)
Cetyl Alcohol (UNII: 936JST6JCN)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Olive Oil (UNII: 6UYK2W1W1E)
Tocopherol (UNII: R0ZB2556P8)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)
Horse Chestnut (UNII: 3C18L6RJAZ)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
Chamaemelum Nobile Flower (UNII: O2T154T6OG)

Product Characteristics
Color	WHITE (Off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24286-1570-1	1 in 1 BOX	06/01/2017
1		28 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 FINAL	part347	06/01/2017

Labeler - DLC Laboratories, Inc. (093351930)

Establishment
Name	Address	ID/FEI	Business Operations
DLC Laboratories, Inc.		093351930	MANUFACTURE(24286-1570) , LABEL(24286-1570)