Ivarest®

Ivarest®
SPL v3
SPL
SPL Set ID 6f68cbbb-6269-4bb3-8cc9-50b146703b42
Route
TOPICAL
Published
Effective Date 2024-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (14 g) Benzyl Alcohol (10.5 g) Diphenhydramine (2 g)
Inactive Ingredients
Bentonite Benzethonium Chloride Lanolin Alcohols Lanolin Oil Magnesium Aluminum Silicate Menthol, Unspecified Form Polyethylene Glycol, Unspecified Petrolatum Polyethylene Glycol 200 Polyglyceryl-3 Diisostearate Polysorbate 60 Propylene Glycol Water D&c Red No. 33 Sorbitan Monostearate Squalane Fd&c Yellow No. 5 Fd&c Yellow No. 6 Camphor (synthetic) Povidone-iodine Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-12-31

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • for the temporary relief of pain and itching associated with poison ivy, poison oak, poison sumac, insect bites or minor skin irritations.
  • dries the oozing and weeping of poison:
    • ivy
    • oak
    • sumac
Section 42229-5

Drug Facts

Section 50565-1

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

Section 55105-1
Active ingredients Purpose
Calamine 14.0 % (w/w) Skin protectant
Benzyl Alcohol 10.5 % (w/w) External analgesic
Diphenhydramine Hydrochloride 2.0 % (w/w) External analgesic
Warnings

For external use only

Directions
  • do not use more often than directed
  • as soon as possible after exposure, wash affected area with soap and water (or Ivarest Poison Ivy Cleansing Foam). Gently pat dry.
  • apply Ivarest liberally to form a layer you can not see through.
  • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
Do Not Use
  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Other Information

Avoid contact with clothing. Ivarest may stain certain fabrics.

Inactive Ingredients

bentonite, benzethonium chloride, camphor, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, lanolin alcohol, lanolin oil, magnesium aluminum silicate, menthol, petrolatum, polyethylene glycol, polyglyceryl-3 diisostearate, polysorbate 60, propylene glycol, purified water, PVP, red 33, sorbitan stearate, squalane, yellow 5, yellow 6

Ask A Doctor Before Use
  • on chicken pox
  • on measles
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
Principal Display Panel 56 G Tube Carton

Long Lasting Cream

NDC 10157-9077-1

MAXIMUM STRENGTH

IVAREST®

EXTERNAL ANALGESIC/

POISON IVY, OAK, SUMAC DRYING CREAM

POISON IVY

ITCH CREAM

8 Hour

Relief

Double

Relief

Formula

  • 1
    Antihistamine

    helps stop the reaction
  • 2
    Analgesic

    soothes itch fast

Plus ... Skin protectant to help dry the rash

Poison Ivy, Oak & Sumac,

Insect Bites, Minor Skin Irritations

Net Wt. 2 oz. (56 g)


Structured Label Content

Uses
  • for the temporary relief of pain and itching associated with poison ivy, poison oak, poison sumac, insect bites or minor skin irritations.
  • dries the oozing and weeping of poison:
    • ivy
    • oak
    • sumac
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
Calamine 14.0 % (w/w) Skin protectant
Benzyl Alcohol 10.5 % (w/w) External analgesic
Diphenhydramine Hydrochloride 2.0 % (w/w) External analgesic
Warnings

For external use only

Directions
  • do not use more often than directed
  • as soon as possible after exposure, wash affected area with soap and water (or Ivarest Poison Ivy Cleansing Foam). Gently pat dry.
  • apply Ivarest liberally to form a layer you can not see through.
  • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
Do Not Use (Do not use)
  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Other Information (Other information)

Avoid contact with clothing. Ivarest may stain certain fabrics.

Inactive Ingredients (Inactive ingredients)

bentonite, benzethonium chloride, camphor, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, lanolin alcohol, lanolin oil, magnesium aluminum silicate, menthol, petrolatum, polyethylene glycol, polyglyceryl-3 diisostearate, polysorbate 60, propylene glycol, purified water, PVP, red 33, sorbitan stearate, squalane, yellow 5, yellow 6

Ask A Doctor Before Use (Ask a doctor before use)
  • on chicken pox
  • on measles
When Using This Product (When using this product)
  • do not get into eyes.
Stop Use and Ask A Doctor If (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
Principal Display Panel 56 G Tube Carton (PRINCIPAL DISPLAY PANEL - 56 g Tube Carton)

Long Lasting Cream

NDC 10157-9077-1

MAXIMUM STRENGTH

IVAREST®

EXTERNAL ANALGESIC/

POISON IVY, OAK, SUMAC DRYING CREAM

POISON IVY

ITCH CREAM

8 Hour

Relief

Double

Relief

Formula

  • 1
    Antihistamine

    helps stop the reaction
  • 2
    Analgesic

    soothes itch fast

Plus ... Skin protectant to help dry the rash

Poison Ivy, Oak & Sumac,

Insect Bites, Minor Skin Irritations

Net Wt. 2 oz. (56 g)


Advanced Ingredient Data


Raw Label Data

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