SELECT BRAND EXTRA STRENGTH ITCH STOPPING- diphenhydramine hydrochloride gel

Select Brand Extra Strength Itch Stopping by

Drug Labeling and Warnings

Select Brand Extra Strength Itch Stopping by is a Otc medication manufactured, distributed, or labeled by Select Brand, Weeks & Leo Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Diphenhydramine HCl 2%

Purpose

Topical analgesic

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

For external use only.

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
• on measles

When using this product do not get into eyes

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

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 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

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Distributed by:

SELECT BRAND DISTRIBUTORS

Pine Bluff, AR 71603 USA

AC (870) 535-3635

PRINCIPAL DISPLAY PANEL

FOR SKIN USE ONLY

SELECT BRAND

Topical Analgesic

ITCH STOPPING GEL

EXTRA STRENGTH

Diphenhydramine Hydrochloride 2%

4 FL OZ (118mL)

INGREDIENTS AND APPEARANCE

SELECT BRAND EXTRA STRENGTH ITCH STOPPING 
diphenhydramine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15127-055
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	.2 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15127-055-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/11/2012

Labeler - Select Brand (043562370)

Registrant - Weeks & Leo Co., Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	manufacture(15127-055)