AVEENO ANTI ITCH CONCENTRATED- zinc oxide, ferric oxide red, and pramoxine hydrochloride lotion

Aveeno Anti Itch Concentrated by

Drug Labeling and Warnings

Aveeno Anti Itch Concentrated 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 ingredient	Purposes
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 last more than 7 days or clear up and occur again within a few days discontinue use and consult a doctor.
• 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

SPL UNCLASSIFIED SECTION

Dist. by: Johnson & Johnson
Consumer Products Company
Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Dermatologist
Recommended

NEW
Formula!

Aveeno®
ACTIVE NATURALS®

Anti-Itch
CONCENTRATED LOTION

External Analgesic/Skin Protectant

Fast-Acting,
Soothing Itch Relief of:
Poison Ivy/Oak/Sumac,
Insect Bites

Soothes Chicken Pox Rash
And Allergic Itches

With Triple Oat Complex

4 fl. Oz. (118 mL)

INGREDIENTS AND APPEARANCE

AVEENO ANTI ITCH CONCENTRATED 
zinc oxide, ferric oxide red, and pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58232-9910
Route of Administration	TOPICAL

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

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: 58232-9910-2	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/07/2012	12/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	11/07/2012	12/01/2023

Labeler - Johnson & Johnson Consumer Inc. (002347102)