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NDC 37205-0338-16 Anti-Itch Wal-Dryl 2; .1 kg/100L; kg/100L Details

Anti-Itch Wal-Dryl 2; .1 kg/100L; kg/100L

Anti-Itch Wal-Dryl is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE.

Product Information

NDC	37205-0338
Product ID	37205-338_6b19280d-caf4-4f79-bc1c-dfe9e2a678ad
Associated GPIs	90200010102020
GCN Sequence Number	005612
GCN Sequence Number Description	diphenhydramine HCl SPRAY 2 % TOPICAL
HIC3	L3P
HIC3 Description	ANTIPRURITICS,TOPICAL
GCN	28630
HICL Sequence Number	004480
HICL Sequence Number Description	DIPHENHYDRAMINE HCL
Brand/Generic	Generic
Proprietary Name	Anti-Itch Wal-Dryl
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	2; .1
Active Ingredient Units	kg/100L; kg/100L
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Labeler Name	Cardinal Health
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	2022-12-31

Package

Package Images

NDC 37205-0338-16 (37205033816)

Pricing Information	N/A
NDC Package Code	37205-338-16
Billing NDC	37205033816
Package	.059 L in 1 BOTTLE, SPRAY (37205-338-16)
Marketing Start Date	2011-08-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e57ed13d-ed4f-4e74-acbd-bf094246c4c9 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 of 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 or measles

When using this product

do not get into 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 - 25⁰C (68⁰ - 77⁰F)

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

*Not manufactured or distributed by Johnson + Johnson Consumer Products Company, distributor of Benadryl Spray

DISTRIBUTED BY CARDINAL HEALTH DUBLIN OHIO 43017

www.myleader.com 1-800-200-6313

PRINCIPAL DISPLAY PANEL

NDC 37205-338-16 TEAR HERE

LEADER

Compare to the active ingredients in Benadryl Spray

Topical Analgesic • Skin Protectant

Itch Relief Spray

Relieves itching due to insect bites, poison oak or ivy, or other minor skin irritations

2 FL OZ (59 mL)

295.000/295AB

INGREDIENTS AND APPEARANCE

ANTI-ITCH WAL-DRYL

diphenhydramine hcl, zinc acetate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-338
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 kg in 100 L
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	0.1 kg in 100 L

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:37205-338-16	0.059 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/02/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/02/2011

Labeler - Cardinal Health (097537435)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(37205-338)

Revised: 12/2018

Document Id: 6b19280d-caf4-4f79-bc1c-dfe9e2a678ad

Set id: e57ed13d-ed4f-4e74-acbd-bf094246c4c9

Version: 4

Effective Time: 20181207