Label: IVAREST- zinc oxide, benzyl alcohol, and diphenhydramine hydrochloride cream
- NDC Code(s): 10157-9077-1
- Packager: Blistex Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 27, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
-
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.
- Other information
-
Inactive ingredients
bentonite, benzethonium chloride, camphor, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, lanolin alcohol, lanolin oil, magnesium aluminum silicate, menthol, petrolatum, PEG-4, polyglyceryl-3 diisostearate, polysorbate 60, propylene glycol, purified water, PVP, red 33, sorbitan stearate, squalane, yellow 5, yellow 6
-
PRINCIPAL DISPLAY PANEL - 56g Tube Carton
2 Itch Relievers
NDC 10157-9077-1
MAXIMUM STRENGTH
IVAREST®
EXTERNAL ANALGESIC/
POISON IVY, OAK, SUMAC DRYING CREAMPOISON IVY
ITCH RELIEF8 Hour
ReliefMEDICATED ANTI-ITCH CREAM
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 IrritationsNET WT 2 OZ(56g)
-
INGREDIENTS AND APPEARANCE
IVAREST
zinc oxide, benzyl alcohol, and diphenhydramine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-9077 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 14 g in 100 g Benzyl Alcohol (UNII: LKG8494WBH) (Benzyl Alcohol - UNII:LKG8494WBH) Benzyl Alcohol 10.5 g in 100 g Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 2 g in 100 g Inactive Ingredients Ingredient Name Strength bentonite (UNII: A3N5ZCN45C) benzethonium chloride (UNII: PH41D05744) lanolin alcohols (UNII: 884C3FA9HE) lanolin oil (UNII: OVV5IIJ58F) magnesium aluminum silicate (UNII: 6M3P64V0NC) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) petrolatum (UNII: 4T6H12BN9U) polyethylene glycol 200 (UNII: R95B8J264J) polyglyceryl-3 diisostearate (UNII: 46P231IQV8) polysorbate 60 (UNII: CAL22UVI4M) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) D&C red no. 33 (UNII: 9DBA0SBB0L) sorbitan monostearate (UNII: NVZ4I0H58X) squalane (UNII: GW89575KF9) FD&C yellow no. 5 (UNII: I753WB2F1M) FD&C yellow no. 6 (UNII: H77VEI93A8) camphor (synthetic) (UNII: 5TJD82A1ET) povidone-iodine (UNII: 85H0HZU99M) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10157-9077-1 1 in 1 CARTON 12/31/2007 1 56 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 12/31/2007 Labeler - Blistex Inc (005126354) Establishment Name Address ID/FEI Business Operations Blistex Inc 005126354 MANUFACTURE(10157-9077)