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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675), PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)

Available from:

Johnson & Johnson Consumer Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- For temporary relief of pain and itching associated with: minor burns sunburn minor cuts scrapes insect bites minor skin irritations rashes due to poison ivy, poison oak, or poison sumac - minor burns - sunburn - 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 - ivy - oak - sumac

Authorization status:

OTC monograph not final

Summary of Product characteristics

AVEENO ANTI-ITCH CONCENTRATED- ZINC OXIDE, FERRIC OXIDE RED, AND
PRAMOXINE HYDROCHLORIDE LOTION
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 ANTI-ITCH CONCENTRATED LOTION
_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
sunburn
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.
DO NOT USE
on wounds or damaged skin
WHEN USING THIS PRODUCT
do not get into eyes
do not bandage tightly
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
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, Dimethicone, Camphor, Methylparaben, Sodium Chloride, Avena
Sativa (Oat)
Kernel Oil, Avena Sativa (Oat) Kernal Flour, Avena Sativa (Oat) Kernel
Extract
QUESTIONS?
call toll-free 866-428-3366 OR 215-273-8755(collect) www.aveeno.com
Distributed by: JOHNSON &
JOHNSON CONSUMER INC.
Skillman, NJ 08558
PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
DERMATOLOGIST
RECOMMENDED
AVEENO
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
Aveeno
Dermatologist recommended
for over 65 years
WITH TRIP