HILL COUNTRY ESSENTIALS- dimethicone lotion

Hill Country Essentials by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Dimethicone 1.2%

Purpose

Skin Protectant

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

WHEN USING

Do not use deep or puncture wounds  animal bites  serious burns

DO NOT USE

When using this product  keep out of eyes. Rinse with water to remove. 

ASK DOCTOR

Stop use and ask a doctor if  condition worsens  symptoms last more than seven days or clear up and occur again within a few days

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.

Directions

• apply as needed to hands or body when skin feels dry or irritated

Other information

• may stain some fabrics

Inactive ingredients

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, avena sativa (oat) kernel flour, benzyl alcohol, sodium chloride.

Questions or comments?

Contact 1-800-527-7731

PRINCIPAL DISPLAY PANEL

Hill Country Essentials Moisturizing Lotion

8 FL OZ (236mL)

NDC: 37808-995-69

Hill Country Essentials Moisturizing Lotion

18 FL OZ (532mL)

NDC: 37808-995-43

INGREDIENTS AND APPEARANCE

HILL COUNTRY ESSENTIALS 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-995
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	12 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
OATMEAL (UNII: 8PI54V663Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-995-69	236 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2010
2	NDC: 37808-995-43	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/29/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/22/2010

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(37808-995)