AVEENO RESTORATIVE SKIN THERAPY ITCH RELIEF BALM- pramoxine hydrochloride cream

Aveeno Restorative Skin Therapy Itch Relief Balm by

Drug Labeling and Warnings

Aveeno Restorative Skin Therapy Itch Relief 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

Pramoxine HCl (0.5%)

Purpose

External Analgesic

Use

For the temporary relief of itching associated with:

• minor skin irritations

Warnings

For external use only.

When using this product

• Avoid contact with the eyes.

Stop use and ask a doctor if

• condition worsens
• symptoms persist for 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

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
• Children under 2 years of age: ask a doctor.

Other Information

Store at Room Temperature

Inactive Ingredients

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Panthenol, Dimethicone, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Cetyl Hydroxyethylcellulose, Chlorphenesin, Steareth-20, Aloe Barbadensis Leaf Extract, Sodium Chloride, Avena Sativa (Oat) Kernel Extract

Questions?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

DERMATOLOGIST RECOMMENDED
NEW
Aveeno ®
RESTORATIVE
SKIN THERAPY
SENSITIVE, DISTRESSED, DRY SKIN
Itch Relief Balm
Pramoxine HCL external analgesic
prebiotic oat
concentrate,
aloe & pro-vit B5
instantly soothes
& helps relieve itch
net wt. 4 oz (113g)

INGREDIENTS AND APPEARANCE

AVEENO RESTORATIVE SKIN THERAPY ITCH RELIEF BALM 
pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0637
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
PANTHENOL (UNII: WV9CM0O67Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
OATMEAL (UNII: 8PI54V663Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CHLORPHENESIN (UNII: I670DAL4SZ)
STEARETH-20 (UNII: L0Q8IK9E08)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OAT (UNII: Z6J799EAJK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0637-4	1 in 1 CARTON	08/01/2020
1		113 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 not final	part348	08/01/2020

Labeler - Johnson & Johnson Consumer Inc. (118772437)