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NDC 00363-0353-04 Itch Relief Gel 2.03 g/100g Details
Itch Relief Gel 2.03 g/100g
Itch Relief Gel is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 00363-0353-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
Diphenhydramine, an antihistamine, is used to relieve the itching of insect bites, sunburns, bee stings, poison ivy, poison oak, and minor skin irritation. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 00363-0353-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine Topical
Product Information
| NDC | 00363-0353 |
|---|---|
| Product ID | 0363-0353_d6073657-e413-35ec-e053-2a95a90ad2d7 |
| Associated GPIs | |
| 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 | Itch Relief Gel |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diphenhydramine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 2.03 |
| Active Ingredient Units | g/100g |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | Walgreens |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 00363-0353-04 (00363035304)
| NDC Package Code | 0363-0353-04 |
|---|---|
| Billing NDC | 00363035304 |
| Package | 120.06 g in 1 TUBE (0363-0353-04) |
| Marketing Start Date | 2018-05-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 487060a7-dff3-4840-b967-ca919f8d0a29 Details
Use
Do not use:
Stop use and ask a doctor if
Keep out of reach of children.
Directions
Inactive ingredients
INGREDIENTS AND APPEARANCE
| ITCH RELIEF GEL
diphenhydramine hcl gel |
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| Labeler - Walgreens (008965063) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Unipack, Inc. | 009248480 | manufacture(0363-0353) | |