Aveeno Active Naturals Eczema Therapy Moisturizing Lotion

Aveeno Active Naturals Eczema Therapy Care by

Drug Labeling and Warnings

Aveeno Active Naturals Eczema Therapy Care by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AVEENO ACTIVE NATURALS ECZEMA THERAPY CARE- oatmeal 
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 Active Naturals Eczema Therapy Moisturizing Lotion

Aveeno Eczema Therapy Bath Treatment
OTC

Drug Facts

Active Ingredients

Colloidal oatmeal (100% )

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to

  • Poison Ivy, oak or sumac
  • Insect bites
  • Rashes
  • Eczema

Warnings

For external use only.

When using this product

  • Do not get into eyes. To avoid slipping, use mat in tub or shower

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.

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

Directions

  • Turn warm water faucet on to full force
  • Slowly sprinkle packet of colloidal oatmeal directly under the faucet into the tub or container
  • Stir any colloidal oatmeal settled on the bottom

Other Information

Store at room temperature.

Questions?

Call 1-866-428-3366. Outside US dial collect 215-273-8755 or visit www.aveeno.com

Aveeno Active Naturals Eczema Therapy Moisturizing Lotion

Drug Facts

Active Ingredients

Colloidal oatmeal (1%)

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to

  • Eczema
  • Rashes

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.

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

Directions

  • Apply as needed

Inactive Ingredients

water, glycerin, distearyldimonimum chloride, panthenol, petrolatum, isopropyl palmitate, cetyl alcohol, dimethicone, Avena Sativa (oat) kernel oil, steareth-20, Avena Sativa (oat) kernel extract, benzalkonium chloride, ceramide NP, sodium chloride

Questions?

Call 1-866-428-3366 or visit www.aveeno.com

Distributed in the US by:
JOHNSON & JOHNSON
CONSUMER PRODUCTS COMPANY
Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL

new

Aveeno®
ACTIVE NATURALS®
Eczema
Therapy
CARE KIT
colloidal oatmeal skin protectant

STEP 1: Soak
STEP 2: Seal in Moisture

Helps relieve
uncomfortable
eczema symptoms
Steroid-free,
Fragrance-free

DERMATOLOGIST
RECOMMENDED

Kit Includes:
AVEENO® Eczema Therapy Bath Treatment | 6 packets – Net Wt. 1.5 oz. (42g) each
AVEENO® Eczema Therapy Moisturizing Cream | Net wt. 5 oz. (140g)

Principal Display Panel
AVEENO ACTIVE NATURALS ECZEMA THERAPY CARE 
oatmeal kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58232-0527
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58232-0527-91 in 1 CARTON02/22/201205/01/2015
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 POUCH 252 g
Part 21 TUBE 140 g
Part 1 of 2
AVEENO ECZEMA THERAPY BATH TREATMENT 
oatmeal powder
Product Information
Item Code (Source)NDC: 58232-0526
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y) Oatmeal1000 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58232-0526-442 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34702/22/2012
Part 2 of 2
AVEENO ACTIVE NATURALS ECZEMA THERAPY MOISTURIZING 
oatmeal cream
Product Information
Item Code (Source)NDC: 58232-1403
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y) Oatmeal10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Distearyldimonium Chloride (UNII: OM9573ZX3X)  
Panthenol (UNII: WV9CM0O67Z)  
Petrolatum (UNII: 4T6H12BN9U)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Dimethicone (UNII: 92RU3N3Y1O)  
Oat Kernel Oil (UNII: 3UVP41R77R)  
Steareth-20 (UNII: L0Q8IK9E08)  
Oat (UNII: Z6J799EAJK)  
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Sodium Chloride (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58232-1403-3140 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34705/01/201009/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/22/201205/01/2015
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 12/2019
Document Id: ff96b250-4955-4883-a95e-04eb3cc94cd0
Set id: 93b4e84d-b5cf-4021-ad9b-c3a1a0708467
Version: 4
Effective Time: 20191226
 
Johnson & Johnson Consumer Inc.