Extra Strength

SPL v12

SPL

SPL Set ID 0bc3800e-7db4-192a-e054-00144ff88e88

Route

TOPICAL

Published

Effective Date 2015-01-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (.2 g)

Inactive Ingredients

Citric Acid Monohydrate Diazolidinyl Urea Hypromelloses Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Alcohol Camphor (synthetic)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2012-07-11

Description

Drug Facts

Purpose

Topical analgesic

Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Uses

temporarily relieves pain and itching associated with:
- insect bites
- minor burns
- sunburn
- minor skin irritations
- minor cuts
- scrapes
- rashes due to poison ivy, poison oak, and poison sumac

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product do not get into eyes

Section 51945-4

FOR SKIN USE ONLY

SELECT BRAND

Topical Analgesic

ITCH STOPPING GEL

EXTRA STRENGTH

Diphenhydramine Hydrochloride 2%

4 FL OZ (118mL)

Warnings

For external use only.

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

Do Not Use

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

Active Ingredient

Diphenhydramine HCl 2%

Other Information

store at 20 ^oC to 25 ^oC (68 ^oF to 77 ^oF)

Inactive Ingredients

camphor, citric acid, diazolidinyl urea, hypromellose, methylparaben, propylene glycol, propylparaben, purified water, SD alcohol 40-B, sodium citrate

Ask A Doctor Before Use

on chicken pox
on measles

Stop Use and Ask A Doctor If

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days

Structured Label Content

Uses

temporarily relieves pain and itching associated with:
- insect bites
- minor burns
- sunburn
- minor skin irritations
- minor cuts
- scrapes
- rashes due to poison ivy, poison oak, and poison sumac

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product do not get into eyes

Section 51945-4 (51945-4)

FOR SKIN USE ONLY

SELECT BRAND

Topical Analgesic

ITCH STOPPING GEL

EXTRA STRENGTH

Diphenhydramine Hydrochloride 2%

4 FL OZ (118mL)

Purpose

Topical analgesic

Warnings

For external use only.

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

Do Not Use (Do not use)

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

Active Ingredient (Active ingredient)

Diphenhydramine HCl 2%

Other Information (Other information)

store at 20 ^oC to 25 ^oC (68 ^oF to 77 ^oF)

Inactive Ingredients (Inactive ingredients)

camphor, citric acid, diazolidinyl urea, hypromellose, methylparaben, propylene glycol, propylparaben, purified water, SD alcohol 40-B, sodium citrate

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

on chicken pox
on measles

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves pain and itching associated with: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product do not get into eyes", "51945-4": "FOR SKIN USE ONLY SELECT BRAND Topical Analgesic ITCH STOPPING GEL EXTRA STRENGTH Diphenhydramine Hydrochloride 2% 4 FL OZ (118mL)", "Purpose": "Topical analgesic", "Warnings": "For external use only.", "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", "Do not use": "on large areas of the body with any other product containing diphenhydramine, even one taken by mouth", "Active ingredient": "Diphenhydramine HCl 2%", "Other information": "store at 20 o C to 25 o C (68 o F to 77 o F)", "Inactive ingredients": "camphor, citric acid, diazolidinyl urea, hypromellose, methylparaben, propylene glycol, propylparaben, purified water, SD alcohol 40-B, sodium citrate", "Ask a doctor before use": "on chicken pox on measles", "Stop use and ask a doctor if": "condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:53.039219 · Updated: 2026-03-14T22:53:55.198203