NDC Code(s) : 54565-1305-1
Packager : Les Emballages Knowlton Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aveeno Skin Relief Gentle Scent Dimethicone LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54565-1305
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE13 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)
CHLORPHENESIN(UNII: I670DAL4SZ)
STEARETH-2(UNII: V56DFE46J5)
OAT KERNEL OIL(UNII: 3UVP41R77R)
DIHYDROMYRCENOL(UNII: 46L1B02ND9)
METHYL DIHYDROJASMONATE (SYNTHETIC)(UNII: 3GW44CIE3Y)
TRICYCLODECENYL PROPIONATE(UNII: 7MGZ636C87)
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES(UNII: 2JU6ZH6GRE)
CHAMOMILE(UNII: FGL3685T2X)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
OAT(UNII: Z6J799EAJK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54565-1305-1354 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product11/07/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 08/01/2015

PRINCIPAL DISPLAY PANEL

new

gentle scent

Aveeno ®

ACTIVE NATURALS ®

skin relief

gentle scent lotion

soothing oat and chamomile

dimethicone skin protectant

as gentle as fragrance free™

relieves itchy, extra-dry skin

CLINICALLY TESTED

THERAPEUTIC

TRIPLE OAT FORMULA

DERMATOLOGIST

RECOMMENDED

12 FL. OZ. (354 mL)

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label