Leader 295.000/295ab

SPL v24

SPL

SPL Set ID 3ed7b8a1-012f-459d-878c-813b93d4673c

Route

TOPICAL

Published

Effective Date 2025-07-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (20 mg) Zinc Cation (1 mg)

Inactive Ingredients

Alcohol Glycerin Povidone Water Tromethamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2011-08-02

Description

Diphenhydramine HCl 2% Zinc Acetate 0.1%

Purpose

External analgesic Skin protectant

Adverse Reactions

Dist. by CAH, Dublin, OH 43017 2019 Cardinal Health

Medication Information

Purpose

External analgesic

Skin protectant

Adverse Reactions

Dist. by CAH, Dublin, OH 43017

2019 Cardinal Health

Description

Diphenhydramine HCl 2% Zinc Acetate 0.1%

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.

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

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company of the registered trademark Benadryl Extra Strength Spray.

Do Not Use

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

Other Information

• store at 20⁰ - 25⁰C (68⁰ - 77⁰F)

Active Ingredients

Diphenhydramine HCl 2%

Zinc Acetate 0.1%

Inactive Ingredients

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

Questions & Comments?

1-888-593-0593

Ask A Doctor Before Use

on chicken pox or measles

When Using This Product

do not get in eyes

Principal Display Panel

TEAR HERE

LEADER™

NDC 70000-0023-1

Extra Strength

Itch Relief Spray

Diphenhydramine HCI, 2%

Zinc Acetate, 0.1%

External Analgesic

Skin Protectant

COMPARE TO BENADRYL ^®EXTRA STRENGTH SPRAY active ingredients*

100% Money Back Guarantee

Relieves Itching

Due to Insect Bites,

Poison Oak or Ivy, or Other Minor Skin Irritations

2 FL OZ (59 mL)

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.

Structured Label Content

Uses

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

Purpose

External analgesic

Skin protectant

Warnings

For external use only

Flammable

Keep away from fire of flame.

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

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company of the registered trademark Benadryl Extra Strength Spray.

Do Not Use (Do not use)

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

Adverse Reactions (Adverse reactions)

Dist. by CAH, Dublin, OH 43017

2019 Cardinal Health

Other Information (Other information)

• store at 20⁰ - 25⁰C (68⁰ - 77⁰F)

Active Ingredients (Active ingredients)

Diphenhydramine HCl 2%

Zinc Acetate 0.1%

Inactive Ingredients (Inactive ingredients)

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

Questions & Comments? (Questions & comments?)

1-888-593-0593

Ask A Doctor Before Use (Ask a doctor before use)

on chicken pox or measles

When Using This Product (When using this product)

do not get in eyes

Principal Display Panel (principal display panel)

TEAR HERE

LEADER™

NDC 70000-0023-1

Extra Strength

Itch Relief Spray

Diphenhydramine HCI, 2%

Zinc Acetate, 0.1%

External Analgesic

Skin Protectant

COMPARE TO BENADRYL ^®EXTRA STRENGTH SPRAY active ingredients*

100% Money Back Guarantee

Relieves Itching

Due to Insect Bites,

Poison Oak or Ivy, or Other Minor Skin Irritations

2 FL OZ (59 mL)

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROMETHAMINE", "unii": "023C2WHX2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the temporary relief of pain and itching associated with minor skin irritations dries the oozing and weeping of poison: ivy, oak, sumac", "Purpose": "External analgesic Skin protectant", "Warnings": "For external use only", "Flammable": "Keep away from fire of flame.", "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", "Disclaimer": "*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company of the registered trademark Benadryl Extra Strength Spray.", "Do not use": "on large areas of the body with any other product containing diphenhydramine, even one taken by mouth", "Adverse reactions": "Dist. by CAH, Dublin, OH 43017 2019 Cardinal Health", "Other information": "• store at 20⁰ - 25⁰C (68⁰ - 77⁰F)", "Active ingredients": "Diphenhydramine HCl 2% Zinc Acetate 0.1%", "Inactive ingredients": "alcohol, glycerin, povidone, purified water, tris (hydroxymethyl)aminomethane", "Questions & comments?": "1-888-593-0593", "Ask a doctor before use": "on chicken pox or measles", "When using this product": "do not get in eyes", "principal display panel": "TEAR HERE LEADER™ NDC 70000-0023-1 Extra Strength Itch Relief Spray Diphenhydramine HCI, 2% Zinc Acetate, 0.1% External Analgesic Skin Protectant COMPARE TO BENADRYL ® EXTRA STRENGTH SPRAY active ingredients* 100% Money Back Guarantee Relieves Itching Due to Insect Bites, Poison Oak or Ivy, or Other Minor Skin Irritations 2 FL OZ (59 mL)", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:28.079565 · Updated: 2026-03-14T23:12:40.778283