HILL COUNTRY ESSENTIALS- oil free daily acne scrub cream

Hill Country Essentials by

Drug Labeling and Warnings

Hill Country Essentials by is a Otc medication manufactured, distributed, or labeled by H.E.B. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses

For the treatment of acne.

Warnings

For external use only  May stain or damage some fabrics, materials or surfaces.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmicist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

WHEN USING

When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DRUG INTERACTIONS

Sunburn Alert: This product contains alpha-hydroxy acid (AHA) that may increase skin's sensitivity to the sun and increase your risk of sunburn. Use a sunscreen and limit sun exposure while using this product and for two weeks afterward.

Directions

Use twice a day. Apply to wet face and neck and massage gently as it lasthers. Rinse thoroughly.

Inactive ingredients

water, cetyl alcohol, PPG-15 stearyl ether, polyethylene, glycolic acid, glycerin, polysorbate 60, steareth-21, C12-15 alkyl lactate, tocopheryl acetate, tetrahexyldecyl ascorbate, butyrospermum parkii (shea butter), cetyl lactate, BHT, neopentyl glycol dicaprylate/dicaprate, cocamidopropyl PG-dimonium chloride phosphate, potassium cetyl phosphate, disodium EDTA, xanthan gum, sodium chloride, sodium benzotriazolyl butylphenol sulfonate, sodium hydroxide, agar, corn starch/acrylamide/sodium copolymer, menthol, benzalkonium chloride, iron oxide, mica, red 40, red 30, yellow 5, fragrance

PRINCIPAL DISPLAY PANEL

Hill Country Essentials Oil Free Daily Acne Scrub

4.2 FL OZ (125mL)

NDC: 37808-963-73

INGREDIENTS AND APPEARANCE

HILL COUNTRY ESSENTIALS 
oil free daily acne scrub cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-963
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETYL ALCOHOL (UNII: 936JST6JCN)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCOLIC ACID (UNII: 0WT12SX38S)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARETH-21 (UNII: 53J3F32P58)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
SHEA BUTTER (UNII: K49155WL9Y)
CETYL LACTATE (UNII: A7EVH2RK4O)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
AGAR (UNII: 89T13OHQ2B)
MENTHOL (UNII: L7T10EIP3A)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-963-73	125 mL in 1 TUBE; Type 0: Not a Combination Product	08/31/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/31/2011

Labeler - H.E.B (007924756)

Registrant - Fruit of the Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of the Earth, Inc.		008193513	manufacture(37808-963)