EARTHS CARE ARTHRITIS: Package Insert and Label Information

EARTHS CARE ARTHRITIS- capsaicin cream
DLC Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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)

PRINCIPAL DISPLAY PANEL -- 68 g Tube Box
(click image for full-size original)
EARTHS CARE ARTHRITIS
capsaicin cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1559
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX
SHEA BUTTER
CETEARYL GLUCOSIDE
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
GLYCERIN
GLYCERYL MONOSTEARATE
HEPTYL UNDECYLENATE
HYDROGENATED CASTOR OIL
RICE BRAN
PHENOXYETHANOL
POTASSIUM SORBATE
ALMOND OIL
WATER
SODIUM STEAROYL GLUTAMATE
SODIUM STEAROYL LACTYLATE
STEARIC ACID
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24286-1559-2 1 TUBE in 1 BOX contains a TUBE
1 68 g in 1 TUBE This package is contained within the BOX (24286-1559-2)
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 Operations
DLC Laboratories, Inc. 093351930 MANUFACTURE (24286-1559), LABEL (24286-1559)

Revised: 11/2018 DLC Laboratories, Inc.

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