Search by Drug Name or NDC

NDC 10157-9077-01 Ivarest 10.5; 2; 14 g/100g; g/100g; g/100g Details

Ivarest 10.5; 2; 14 g/100g; g/100g; g/100g

Ivarest is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Blistex Inc. The primary component is BENZYL ALCOHOL; DIPHENHYDRAMINE HYDROCHLORIDE; ZINC OXIDE.

Product Information

NDC	10157-9077
Product ID	10157-9077_25cfcb6e-4432-4cbd-936e-0d0d3c39d0f5
Associated GPIs	90209903403720
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Ivarest
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide, Benzyl Alcohol, and Diphenhydramine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10.5; 2; 14
Active Ingredient Units	g/100g; g/100g; g/100g
Substance Name	BENZYL ALCOHOL; DIPHENHYDRAMINE HYDROCHLORIDE; ZINC OXIDE
Labeler Name	Blistex Inc
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Pediculicide [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10157-9077-01 (10157907701)

Pricing Information	N/A
NDC Package Code	10157-9077-1
Billing NDC	10157907701
Package	1 TUBE in 1 CARTON (10157-9077-1) / 56 g in 1 TUBE
Marketing Start Date	2007-12-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6f68cbbb-6269-4bb3-8cc9-50b146703b42 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

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

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

Warnings

For external use only

Do not use

on large areas of the body
with any other product containing diphenhydramine, even one taken by mouth

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

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

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

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, 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 CREAM

POISON IVY

ITCH RELIEF

8 Hour

Relief

MEDICATED 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 Irritations

NET WT 2 OZ(56g)

Principal Display Panel - 56g Tube Carton

INGREDIENTS AND APPEARANCE

IVAREST

zinc oxide, benzyl alcohol, and diphenhydramine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10157-9077
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	12/31/2007

Labeler - Blistex Inc (005126354)

Name	Address	ID/FEI	Business Operations
Establishment
Blistex Inc		005126354	MANUFACTURE(10157-9077)

Revised: 12/2019

Document Id: 25cfcb6e-4432-4cbd-936e-0d0d3c39d0f5

Set id: 6f68cbbb-6269-4bb3-8cc9-50b146703b42

Version: 2

Effective Time: 20191227

Search by Drug Name or NDC

NDC 10157-9077-01 Ivarest 10.5; 2; 14 g/100g; g/100g; g/100g Details

Ivarest 10.5; 2; 14 g/100g; g/100g; g/100g

Product Information

Package

Package Images

NDC 10157-9077-01 (10157907701)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 6f68cbbb-6269-4bb3-8cc9-50b146703b42 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do not use

Ask a doctor before use

When using this product

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL - 56g Tube Carton

INGREDIENTS AND APPEARANCE

Migranal Generic Name Question

Can You Take A Z-Pak If You Have A Penicillin Allergy?