AVEENO CRACKED SKIN RELIEF CICA BALM- dimethicone emulsion 
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Aveeno ® CRACKED SKIN RELIEF CICA balm

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

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

PRINCIPAL DISPLAY PANEL - 312 g Jar Label

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

PRINCIPAL DISPLAY PANEL - 312 g Jar Label
AVEENO CRACKED SKIN RELIEF CICA BALM 
dimethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0350-128 g in 1 JAR; Type 0: Not a Combination Product09/01/201804/12/2022
2NDC:69968-0350-2312 g in 1 JAR; Type 0: Not a Combination Product09/01/201809/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/01/201809/12/2022
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 10/2022
Document Id: eb8255a1-0c41-37d7-e053-2a95a90a70b1
Set id: 94e0e460-1f88-4b9e-9de3-8ab120e180e1
Version: 5
Effective Time: 20221020
 
Johnson & Johnson Consumer Inc.