AVEENO SKIN RELIEF MOISTURIZING FRAGRANCE FREE- dimethicone lotion

Aveeno Skin Relief Moisturizing by

Drug Labeling and Warnings

Aveeno Skin Relief Moisturizing by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Dimethicone 1.2%

Purpose

Skin Protectant

Uses

• Helps prevent and temporarily protects chafed, chapped, or cracked skin
• Helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only.

When using this product

• do not get into eyes.

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.

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

Directions

Apply as needed.

Other Information

Store at Room Temperature.

Inactive Ingredients

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Avena Sativa (Oat) Kernel Oil, Steareth-20, Sodium Chloride, Butyrospermum Parkii (Shea) Butter, Avena Sativa (Oat) Kernel Extract

Questions?

Call toll-free 866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 532 mL Bottle Label

NEW LOOK
SAME GREAT FORMULA
Aveeno®

SKIN RELIEF
MOISTURIZING
lotion
Dimethicone skin protectant
Helps Heal
Very Dry Skin
Clinically proven
Soothes sensitive or
itchy, extra-dry skin
DERMATOLOGIST
THERAPEUTIC
RECOMMENDED BRAND
fragrance free
with
TRIPLE OAT COMPLEX
& NATURAL SHEA BUTTER

18 fl oz (532 mL)

INGREDIENTS AND APPEARANCE

AVEENO SKIN RELIEF MOISTURIZING   FRAGRANCE FREE
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0408
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)
Oat Kernel Oil (UNII: 3UVP41R77R)
Steareth-20 (UNII: L0Q8IK9E08)
Sodium Chloride (UNII: 451W47IQ8X)
Shea Butter (UNII: K49155WL9Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0408-1	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2005
2	NDC: 69968-0408-8	227 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2005
3	NDC: 69968-0408-2	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2005
4	NDC: 69968-0408-3	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2005
5	NDC: 69968-0408-4	24 in 1 CARTON	12/01/2005
5		29 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/01/2005

Labeler - Johnson & Johnson Consumer Inc. (002347102)