OATMEAL DAILY MOISTURIZING 8OZ.- dimethicone lotion

Oatmeal Daily Moisturizing 8oz. by

Drug Labeling and Warnings

Oatmeal Daily Moisturizing 8oz. by is a Otc medication manufactured, distributed, or labeled by BRANDS INTERNATIONAL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose

Dimethicone 1.3% ......... Skin Protectant

PURPOSE

Skin protectant

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses

• Temporarily protects chafed, chapped or cracked skin

WARNINGS

Warnings For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if condition worsens. Symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on

• Deep or puncture wounds
• Animal bites
• Serious burns

DOSAGE & ADMINISTRATION

Directions apply liberally as often as needed.

OTHER SAFETY INFORMATION

Other Information store at room temperature.

INACTIVE INGREDIENT

Inactive Ingredients

Water, Isopropyl Myristate, Glycerin, Cetyl Alcohol, Mineral Oil, Fragrance, DMDM Hydantoin, Stearyl Alcohol, Carbomer, Sodium Hydroxide, Aloe Vera Leaf, Vitamin E, Isopropyl Myristate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OATMEAL DAILY MOISTURIZING 8OZ. 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50157-612
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	3 g  in 227 g

Inactive Ingredients
Ingredient Name	Strength
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)
WATER (UNII: 059QF0KO0R)
.BETA.-ELEOSTEARIC ACID (UNII: LA17B88161)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CARBOMER 1342 (UNII: 809Y72KV36)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50157-612-22	227 g in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/22/2023

Labeler - BRANDS INTERNATIONAL (243748238)

Registrant - BRANDS INTERNATIONAL (243748238)

Establishment
Name	Address	ID/FEI	Business Operations
BRANDS INTERNATIONAL		243748238	manufacture(50157-612)