EARTHS CARE ACNE SPOT TREATMENT- sulfur cream

Earths Care Acne Spot Treatment by

Drug Labeling and Warnings

Earths Care Acne Spot Treatment 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

Sulfur 10%

Purpose

Acne medication

Uses

for the treatment of acne

• penetrates the pores and dries and clears pimples and blackheads
• helps to keep new pimples and blackheads from forming

Warnings

For external use only

When using this product

• do not get into eyes
• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
• apply only to areas with acne

Do not use on

• broken skin
• large areas of the skin

Stop use and ask a doctor if

• excessive skin irritation develops or increases

Keep out of reach of children.

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

Directions

• cleanse the skin thoroughly before applying
• cover the entire affected area with a thin layer one to three times daily
• leave on for 10 minutes
• thoroughly remove with water
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive ingredients

Avena sativa (oat) kernel colloidal oatmeal, bentonite, Butyrospermum parkii (shea) butter, cetearyl glucoside, citric acid, glycerin, glyceryl stearate, Helianthus annuus (sunflower) seed oil, hydrogenated castor oil, phenoxyethanol, potassium sorbate, purified water, sodium stearoyl glutamate, xanthan gum

Questions

1-888-602-6380

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 27 g Tube Box

Allergy Tested

EARTH'S
CARE®

* PARABEN *
FREE

Acne
Spot
Treatment

Maximum Strength

Sulfur 10%

Clears and Helps Prevent
Stubborn Blemishes

with Natural Bentonite
and Colloidal Oatmeal

Non-Comedogenic

1%
FOR THE
PLANETSM
MEMBER

0.97 OZ. (27 g)

INGREDIENTS AND APPEARANCE

EARTHS CARE ACNE SPOT TREATMENT 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24286-1557
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OATMEAL (UNII: 8PI54V663Y)
BENTONITE (UNII: A3N5ZCN45C)
SHEA BUTTER (UNII: K49155WL9Y)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24286-1557-1	1 in 1 BOX	01/18/2013
1		27 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 24286-1557-2	2.8 g in 1 POUCH; Type 0: Not a Combination Product	01/18/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/18/2013

Labeler - DLC Laboratories, Inc. (093351930)

Establishment
Name	Address	ID/FEI	Business Operations
DLC Laboratories, Inc.		093351930	manufacture(24286-1557)