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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)
| 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 |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6f68cbbb-6269-4bb3-8cc9-50b146703b42 Details
SPL UNCLASSIFIED SECTION
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.
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)
INGREDIENTS AND APPEARANCE
| IVAREST
zinc oxide, benzyl alcohol, and diphenhydramine hydrochloride cream |
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| Labeler - Blistex Inc (005126354) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| 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