AVEENO ACTIVE NATURALS ECZEMA THERAPY MOISTURIZING- oatmeal cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y)
Available from:
Johnson & Johnson Consumer Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Skin protectant Temporarily protects and helps relieve minor skin irritation and itching due to: - Eczema - Rashes
Authorization status:
OTC monograph final
Authorization number:
69968-0065-1, 69968-0065-5, 69968-0065-7, 69968-0065-9

AVEENO ACTIVE NATURALS ECZEMA THERAPY MOISTURIZING- oatmeal cream

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 CREAM

Drug Facts

Active ingredient

Colloidal oatmeal 1%

Purpos e

Skin protectant

Us es

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 right

away.

Directions

Apply as needed

Other information

For use on mild to moderate eczema or as directed by a physician. Store at room temperature.

Inactive ingredients

Water, Glycerin, Panthenol, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl

Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Oil, Steareth-20, Benzalkonium Chloride, Ceramide

NP, Sodium Chloride, Avena Sativa (Oat) Kernel Extract

Ques tions ?

®

®

866-4AVEENO; Outside US, dial collect 215-273-8755 or visit www.aveeno.com

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 206 g Tube Label

Aveeno

ACTIVE NATURALS

Eczema

Therapy

MOISTURIZING

CREAM

colloidal oatmeal skin protectant

Relieves dry, itchy, irritated

skin due to eczema

Clinically shown to soothe

skin with eczema

Steroid-free, fragrance-free

DERMATOLOGIST

RECOMMENDED

ACCEPTED

NATIONALECZEMA.ORG

NATIONAL

ECZEMA

ASSOCIATION

Net Wt.7.3 oz. (206 g)

®

®

AVEENO ACTIVE NATURALS ECZEMA THERAPY MOISTURIZING

oatmeal cream

Product Information

Johnson & Johnson Consumer Inc.

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 9 6 8 -0 0 6 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O a tmea l (UNII: 8 PI54V6 6 3Y) (Oatmeal - UNII:8 PI54V6 6 3Y)

O a tme a l

10 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Glycerin (UNII: PDC6 A3C0 OX)

Pa ntheno l (UNII: WV9 CM0 O6 7Z)

Distea ryldimo nium Chlo ride (UNII: OM9 573ZX3X)

Petro la tum (UNII: 4T6 H12BN9 U)

Iso pro pyl Pa lmita te (UNII: 8 CRQ2TH6 3M)

Cetyl Alco ho l (UNII: 9 36 JST6 JCN)

Dimethico ne (UNII: 9 2RU3N3Y1O)

O a t Kernel O il (UNII: 3UVP41R77R)

Stea reth-2 0 (UNII: L0 Q8 IK9 E0 8 )

Benza lko nium Chlo ride (UNII: F5UM2KM3W7)

Cera mide NP (UNII: 4370 DF0 50 B)

So dium Chlo ride (UNII: 451W47IQ8 X)

O a t (UNII: Z6 J79 9 EAJK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 9 6 8 -0 0 6 5-5

141 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 1/20 13

10 /31/20 20

2

NDC:6 9 9 6 8 -0 0 6 5-7

20 6 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 1/20 13

10 /22/20 20

3

NDC:6 9 9 6 8 -0 0 6 5-9

354 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 1/20 13

12/24/20 20

4

NDC:6 9 9 6 8 -0 0 6 5-1

14 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 1/20 13

11/0 1/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt347

0 4/0 1/20 13

12/24/20 20

Labeler -

Johnson & Johnson Consumer Inc. (002347102)

Revised: 4/2019

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