Quality Choice Extra Strength Itch Stopping Gel

Quality Choice Extra Strength Itch Stopping Gel
SPL v6
SPL
SPL Set ID 884c9b47-d511-1d17-e053-2995a90a42eb
Route
TOPICAL
Published
Effective Date 2014-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (2 g)
Inactive Ingredients
Diazolidinyl Urea Methylparaben Trisodium Citrate Dihydrate Alcohol Water Propylene Glycol Anhydrous Citric Acid Hypromellose 2910 (4000 Mpa.s) Camphor (synthetic) Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-05-14

Description

Diphenhydramine hydrochloride 2%..


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

itching due to:

insect bites

minor burns

sunburn

minor skin irritations

minor cuts

scrapes

rashes due to poison ivy, poison oak, and poison sumac

Dosage and Administration

do not use more often than directed

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

Description

Diphenhydramine hydrochloride 2%..

Other

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

Section 43683-2

Dosage & Administration Section

Added - do not use more often than directed

Section 51727-6

camphor, citric acid, diazolidinyl urea, hypromellose, methylparaben, propylene glycol, propylparaben, purified water,



SD alcohol 40-B, sodium citrate

Section 51945-4

Quality Choice QC

Compare to the active ingredient in Benadryl Gel

Extra strength Itch Relief Gel

Topical Analgesic

Diphenhydramine HCL 2%

For skin use only

Section 55105-1

Anti itch

Topical analgesic

Section 55106-9

Diphenhydramine hydrochloride 2%..

Do Not Use

on large areas of the body

with any other product containing diphenhydramine, even one taken by mouth

Ask Doctor Before Use

On chiken Pox

On Measles

When Using This Product

do not get into eyes

Stop Use and Ask Doctor If

condition worsens

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

Other

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

Indications and Usage (34067-9)

itching due to:

insect bites

minor burns

sunburn

minor skin irritations

minor cuts

scrapes

rashes due to poison ivy, poison oak, and poison sumac

Dosage and Administration (34068-7)

do not use more often than directed

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

Warnings and Precautions (34071-1)

For external use only

Section 43683-2 (43683-2)

Dosage & Administration Section

Added - do not use more often than directed

Section 51727-6 (51727-6)

camphor, citric acid, diazolidinyl urea, hypromellose, methylparaben, propylene glycol, propylparaben, purified water,



SD alcohol 40-B, sodium citrate

Section 51945-4 (51945-4)

Quality Choice QC

Compare to the active ingredient in Benadryl Gel

Extra strength Itch Relief Gel

Topical Analgesic

Diphenhydramine HCL 2%

For skin use only

Section 55105-1 (55105-1)

Anti itch

Topical analgesic

Section 55106-9 (55106-9)

Diphenhydramine hydrochloride 2%..

Do Not Use

on large areas of the body

with any other product containing diphenhydramine, even one taken by mouth

Ask Doctor Before Use

On chiken Pox

On Measles

When Using This Product

do not get into eyes

Stop Use and Ask Doctor If (Stop Use and ask Doctor if)

condition worsens

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


Raw Label Data

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