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NDC 41250-0295-20 Itch Relief 18; 882 mg/mL; mg/mL Details

Itch Relief 18; 882 mg/mL; mg/mL

Itch Relief is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution, Inc. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE.

Product Information

NDC	41250-0295
Product ID	41250-295_eeaf12a0-d7e5-426e-96c3-407831576cd7
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCl, Zinc Acetate
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	18; 882
Active Ingredient Units	mg/mL; mg/mL
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Labeler Name	Meijer Distribution, Inc
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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	2024-12-31

Package

Package Images

NDC 41250-0295-20 (41250029520)

Pricing Information	N/A
NDC Package Code	41250-295-20
Billing NDC	41250029520
Package	59 mL in 1 BOTTLE, SPRAY (41250-295-20)
Marketing Start Date	2018-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e11390ec-99a3-4ff1-a3c8-ca909f4f67b5 Details

Active ingredients

Diphenhydramine HCL 2%

Zinc acetate 0.1%

Purpose

External analgesic

Skin protectant

Uses

for the temporary relief of pain and itching associated with minor skin irritations
dries the oozing and weeping of poison: ivy, oak, sumac

Warnings

For external use only

Flammable. Keep away from fire or flame.

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 in eyes

Stop use and ask a doctor if

condition worsens or 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 than directed
adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: ask a doctor

Other information

store at 20⁰ to 25⁰ C (68⁰ to 77⁰ F)

Inactive ingredients

alcohol, glycerin, povidone, purified water, tris (hydroxymethyl)aminomethane

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Benadryl Spray.

Distributed by Meijer Distribution, Inc.

Grand Rapids, MI 49544

www.meijer.com

principal display panel

TEAR HERE

Meijer

Compare to the active ingredients in Benadryl Spray*

Itch Relief Spray

topical analgesic

skin protectant

Pain & Itch Reliever

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

ITCH RELIEF

diphenhydramine hcl, zinc acetate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-295
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	18 mg in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	882 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
TROMETHAMINE (UNII: 023C2WHX2V)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-295-20	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/01/2018

Labeler - Meijer Distribution, Inc (006959555)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(41250-295)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(41250-295)

Revised: 4/2022

Document Id: eeaf12a0-d7e5-426e-96c3-407831576cd7

Set id: e11390ec-99a3-4ff1-a3c8-ca909f4f67b5

Version: 10

Effective Time: 20220414