MARCS DAILY MOISTURIZING WITH SOY AND NATURAL COLLOIDAL OATMEAL- dimethicone lotion

Marcs by

Drug Labeling and Warnings

Marcs by is a Otc medication manufactured, distributed, or labeled by MARC GLASSMAN, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Marc's Daily Moisturizing Lotion with Soy and Natural Colloidal Oatmeal – Drug Facts

Active ingredients

Dimethicone 1.3%

Purpose

Skin Protectant

Uses

• helps prevent and temporarily protects chaffed, chapped or cracked skin.
• helps protect from the drying effects of wind and cold weather.

Warnings

For external use only

DO NOT USE

Do not use on deep or puncture wounds animal bites serious burns.

WHEN USING

When using this product ​ do not get into eyes

STOP USE

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 or damage some fabrics, materials or surfaces.

Inactive ingredients

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, avena sativa (oat) kernel protein, magnesium
aluminum silicate, sodium chloride, benzyl alcohol.

PRINCIPAL DISPLAY PANEL

Marc's Daily Moisturizing Lotion with Soy and Natural Colloidal Oatmeal

12 FL OZ (354ml)

NDC: 68998-201-52

INGREDIENTS AND APPEARANCE

MARCS  DAILY MOISTURIZING WITH SOY AND NATURAL COLLOIDAL OATMEAL
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68998-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	13 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
OATMEAL (UNII: 8PI54V663Y)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68998-201-52	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/09/2019

Labeler - MARC GLASSMAN, INC. (094487477)

Registrant - Fruit Of The Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(68998-201)