EARTHS CARE ARTHRITIS- capsaicin cream

EARTHS CARE ARTHRITIS by

Drug Labeling and Warnings

EARTHS CARE ARTHRITIS by is a Otc medication manufactured, distributed, or labeled by DLC Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Capsaicin 0.1%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain of muscles and joints associated with:

• arthritis
• simple backache
• strains
• sprains
• bruises

Warnings

For external use only

When using this product

• read leaflet inside carton before use
• use only as directed
• do not bandage tightly or cover treated area
• do not use with a heating pad or other heat sources
• avoid contact with eyes and mucous membranes
• do not apply to wounds, damaged, broken or irritated skin
• a temporary burning sensation may occur upon application but normally disappears within several days
• if a severe burning sensation occurs, stop use immediately and read important information on leaflet inside carton
• do not expose the area treated with product to heat or direct sunlight
• do not apply immediately before or after activities such as bathing, swimming, sunbathing or strenuous exercise

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present
• irritation develops

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 over 18 years:

• apply to affected area
• massage into painful area until thoroughly absorbed
• repeat as necessary, but no more than 3 or 4 times daily
• WASH HANDS WITH SOAP AND COLD WATER AFTER APPLYING

Children 18 years or younger: ask a doctor

Inactive ingredients

beeswax, Butyrospermum parkii (shea) butter, cetearyl glucoside, cetyl alcohol, citric acid, glycerin, glyceryl stearate, heptyl undecylenate, hydrogenated castor oil, Oryza sativa (rice) bran extract, phenoxyethanol, potassium sorbate, Prunus amygdalus dulcis (sweet almond) oil, purified water, sodium stearoyl glutamate, sodium stearoyl lactylate, stearic acid, xanthan gum

Questions

1-888-602-6380

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

PRINCIPAL DISPLAY PANEL - 68 g Tube Box

Odor-Free

EARTH'S
CARE™

NON-GREASY
FORMULA

Arthritis
Cream

High Potency

Capsaicin 0.1%
Penetrating relief for
joint and muscle pain

with Natural Rice Bran
and Almond Oil

External Analgesic

1%
FOR THE
PLANET℠
MEMBER

2.4 OZ. (68 g)

INGREDIENTS AND APPEARANCE

EARTHS CARE ARTHRITIS 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24286-1559
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
RICE BRAN (UNII: R60QEP13IC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALMOND OIL (UNII: 66YXD4DKO9)
WATER (UNII: 059QF0KO0R)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24286-1559-2	1 in 1 BOX	09/25/2013
1		68 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 NOT FINAL	part348	09/25/2013

Labeler - DLC Laboratories, Inc. (093351930)

Establishment
Name	Address	ID/FEI	Business Operations
DLC Laboratories, Inc.		093351930	MANUFACTURE(24286-1559) , LABEL(24286-1559)