AVEENO CALAMINE AND PRAMOXINE HYDROCHLORIDE ANTI ITCH- ferric oxide red, zinc oxide, and 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.

----------

Aveeno Calamine & Pramoxine HCl Anti-Itch Cream

Drug Facts

Active ingredients	Purpose
Calamine 3%	Skin Protectant
Pramoxine HCl 1%	External Analgesic

Uses

For temporary relief of pain and itching associated with minor burns, sunburns, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, or poison sumac
Dries the oozing and weeping of poison ivy/oak/sumac

Warnings

For external use only

When using this product Do not get into 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
Do not apply to wounds or damaged skin.
Do not bandage tightly

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

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: consult a doctor.

Other Information

STORE AT ROOM TEMPERATURE

Inactive ingredients

avena sativa (oat) kernel extract, avena sativa (oat) kernel flour, avena sativa (oat) kernel oil, camphor, cetyl alcohol, dimethicone, distearyldimonium chloride, glycerin, isopropyl palmitate, methylparaben, petrolatum, sodium chloride, water

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 28g Tube Carton

Dermatologist Recommended
Aveeno®
ACTIVE NATURALS®
Calamine & Pramoxine HCl
ANTI-ITCH CREAM
External Analgesic/Skin Protectant
Steroid Free

Effectively relieves Itch from:
Poison Ivy/Oak/Sumac and Insect Bites
Soothes:
Chicken Pox Rash and Allergic Itch

New
Itch Relieving
Formula

Fast-Acting, Soothing Itch Relief
Dries out weepy rashes

NET WT 1 OZ (28g)
With Triple Oat Complex

Principal Display Panel - 28g Tube Carton

AVEENO CALAMINE AND PRAMOXINE HYDROCHLORIDE ANTI ITCH
ferric oxide red, zinc oxide, and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58232-9911
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Ferric Oxide Red (UNII: 1K09F3G675) (Ferric Oxide Red - UNII:1K09F3G675)	Ferric Oxide Red	0.6 mg in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	29.4 mg in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Oat (UNII: Z6J799EAJK)
Oatmeal (UNII: 8PI54V663Y)
Oat Kernel Oil (UNII: 3UVP41R77R)
Cetyl Alcohol (UNII: 936JST6JCN)
Dimethicone (UNII: 92RU3N3Y1O)
Distearyldimonium Chloride (UNII: OM9573ZX3X)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Palmitate (UNII: 8CRQ2TH63M)
Methylparaben (UNII: A2I8C7HI9T)
Petrolatum (UNII: 4T6H12BN9U)
Sodium Chloride (UNII: 451W47IQ8X)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58232-9911-1	1 in 1 CARTON	06/20/2013	12/01/2023
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58232-9911-2	2.8 g in 1 PACKET; Type 0: Not a Combination Product	06/20/2013	12/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	06/20/2013	12/01/2023

Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 1/2019

Document Id: 597a296f-9eb1-466c-a27c-d374e759e8f9

Set id: a042095e-a139-4c5d-8ffb-39e37da2a93a

Version: 2

Effective Time: 20190104

Johnson & Johnson Consumer Inc.