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

Aveeno Calamine and Pramoxine Hydrochloride Anti Itch by

Drug Labeling and Warnings

Aveeno Calamine and Pramoxine Hydrochloride Anti Itch 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

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/20/2013	12/01/2023

Labeler - Johnson & Johnson Consumer Inc. (002347102)