AVEENO CRACKED SKIN RELIEF CICA BALM- dimethicone emulsion

Aveeno CRACKED SKIN RELIEF CICA balm by

Drug Labeling and Warnings

Aveeno CRACKED SKIN RELIEF CICA balm by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient

Dimethicone (5%)

Purpose

Skin Protectant

Use

• 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

Inactive Ingredients

Glycerin, Water, Cetearyl Alcohol, Isocetyl Alcohol, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Ethylhexylglycerin, Sodium Cetearyl Sulfate, Benzoic Acid, Stearic Acid, Dipotassium Phosphate, Potassium Phosphate, Caprylic/Capric Triglyceride, p-Anisic Acid, Sodium Hydroxide, Avena Sativa (Oat) Kernel Oil, Citric Acid, Avena Sativa (Oat) Kernel Extract

Other Information

Store at room temperature.

Questions?

call toll-free 866-428-3366 or 215-273-8755 (collect). www.aveeno.com

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

PRINCIPAL DISPLAY PANEL - 312 g Jar Label

NEW
Aveeno®

CRACKED
SKIN RELIEF
CICA balm
Dimethicone Skin Protectant

Helps Relieve
Cracked Skin

Intensely moisturizes on contact

fragrance free

with
TRIPLE OAT COMPLEX

net wt. 11 oz (312g)

DERMATOLOGIST
THERAPEUTIC
RECOMMENDED BRAND

INGREDIENTS AND APPEARANCE

AVEENO CRACKED SKIN RELIEF CICA BALM 
dimethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0350
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Isocetyl Alcohol (UNII: 1800H64066)
Benzoic acid (UNII: 8SKN0B0MIM)
Cetyl Alcohol (UNII: 936JST6JCN)
OATMEAL (UNII: 8PI54V663Y)
Benzyl Alcohol (UNII: LKG8494WBH)
Ethylhexylglycerin (UNII: 147D247K3P)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
OAT KERNEL OIL (UNII: 3UVP41R77R)
Stearic acid (UNII: 4ELV7Z65AP)
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
p-Anisic Acid (UNII: 4SB6Y7DMM3)
Sodium Hydroxide (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
OAT (UNII: Z6J799EAJK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0350-1	28 g in 1 JAR; Type 0: Not a Combination Product	09/01/2018
2	NDC: 69968-0350-2	312 g in 1 JAR; Type 0: Not a Combination Product	09/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2018

Labeler - Johnson & Johnson Consumer Inc. (002347102)