AVEENO CALM PLUS RESTORE ITCH RELIEF BALM- pramoxine hydrochloride 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 Calm Plus Restore Itch Relief Balm

Drug Facts

Active ingredient

Pramoxine HCl (0.5%)

Purpose

External Analgesic

Uses

For the temporary relief of itching associated with:

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

Other Information

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?

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.


Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 113g Tube Carton

NEW

Aveeno®

Calm +

Restore

ITCH RELIEF

BALM

Pramoxine HCl external analgesic

Sensitive,

Delicate Skin

Instantly soothes

and helps relieve itch

FRAGRANCE FREE

DERMATOLOGIST RECOMMENDED BRAND

PREBIOTIC OAT, ALOE, PRO-VIT B5

net wt.

4 OZ (113 g)

Aveeno_01

AVEENO CALM PLUS RESTORE ITCH RELIEF BALM 
pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0796
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
STEARETH-20 (UNII: L0Q8IK9E08)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
OATMEAL (UNII: 8PI54V663Y)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
OAT (UNII: Z6J799EAJK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0796-41 in 1 CARTON07/03/2023
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/03/2023
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 1/2023
Document Id: f17dcc88-303c-4e1f-e053-2a95a90ae08d
Set id: f17e2409-e8d7-37e0-e053-2a95a90a6026
Version: 1
Effective Time: 20230105
 
Johnson & Johnson Consumer Inc.