Extra Strength SELECT BRAND ITCH STOPPING GEL

Set ID
0bc3800e-7db4-192a-e054-00144ff88e88
Manufacturer
Select Brand | Weeks & Leo Co., Inc.
Effective date
2015-01-08
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-05-31 22:41:19

Key Label Information

Active Ingredients And Purpose

Active ingredient

Diphenhydramine HCl 2%

Purpose

Topical analgesic

Uses

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

Warnings

Warnings

For external use only.

Directions And Dosage

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 Label Information

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FOR SKIN USE ONLY SELECT BRAND Topical Analgesic ITCH STOPPING GEL EXTRA STRENGTH Diphenhydramine Hydrochloride 2% 4 FL OZ (118mL)

Products

NDC Codes

Ingredients

NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
HYPROMELLOSES3NXW29V3WOIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ALCOHOL3K9958V90MIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 2%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

store at 20 o C to 25 o C (68 o F to 77 o F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Distributed by: SELECT BRAND DISTRIBUTORS Pine Bluff, AR 71603 USA AC (870) 535-3635

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FOR SKIN USE ONLY SELECT BRAND Topical Analgesic ITCH STOPPING GEL EXTRA STRENGTH Diphenhydramine Hydrochloride 2% 4 FL OZ (118mL)

Source Document

Official SPL XML cached by FDA.report ยท DailyMed PDF

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XML SHA-256
c942ec4645883ddb7b5229c59a9ed12e3160d2a7236fed98e91733b773b52dc7
XML bytes
22617

Legacy File Index

FolderFileDate
otc0c2b8c34-67bb-3ae9-e054-00144ff8d46c.xml2015-01-09
otcSB_GEL_Back.jpg2015-01-09
otcSB_GEL_PDP.jpg2015-01-09