AVEENO CALM PLUS RESTORE SKIN THERAPY BALM- colloidal oatmeal cream

Aveeno Calm Plus Restore Skin Therapy Balm by

Drug Labeling and Warnings

Aveeno Calm Plus Restore Skin Therapy Balm 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

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Uses

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

• rashes
• eczema
• poison ivy, oak, or sumac
• insect bites

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

• Do not use if quality seal is broken or missing.
• Store at Room Temperature

Inactive ingredients

Water, Glycerin, Panthenol, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Caprylic/Capric Triglyceride, Avena Sativa (Oat) Kernel Oil, Steareth-20, Benzalkonium Chloride, Ceramide NP, Avena Sativa (Oat) Kernel Extract, Sodium Chloride

Questions?

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 - 48g Tube Carton

NEW!

Aveeno®

Calm +

Restore

SKIN THERAPY BALM

Colloidal Oatmeal Skin Protectant

Sensitive Skin

Soothes and deeply

moisturizes to help

strengthen skin’s

natural moisture barrier

STEROID FREE

FRAGRANCE-FREE

DERMATOLOGIST RECOMMENDED BRAND

COLLOIDAL OATMEAL + CERAMIDE

net wt. 1.7 oz (48 g)

INGREDIENTS AND APPEARANCE

AVEENO CALM PLUS RESTORE SKIN THERAPY BALM 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0755
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PANTHENOL (UNII: WV9CM0O67Z)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
STEARETH-20 (UNII: L0Q8IK9E08)
OAT KERNEL OIL (UNII: 3UVP41R77R)
CERAMIDE NP (UNII: 4370DF050B)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
OAT (UNII: Z6J799EAJK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PETROLATUM (UNII: 4T6H12BN9U)
CETYL ALCOHOL (UNII: 936JST6JCN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0755-2	1 in 1 CARTON	07/28/2022
1		48 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/28/2022

Labeler - Kenvue Brands LLC (118772437)