SELECT BRAND ANTI-ITCH- menthol and pramoxine hydrochloride cream

Select Brand Anti-Itch by

Drug Labeling and Warnings

Select Brand Anti-Itch 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 ingredients

Menthol 1%

Pramoxine hydrochloride 1%

Purpose

Topical analgesic

Uses

for temporary relief of pain and itching due to:

• minor burns
• sunburn
• minor cuts
• scrapes
• insect bites
• minor skin irritations
• minor rashes due to poison ivy, poison oak, or poison sumac

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if

• condition gets worse
• 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.

Directions

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

children under 2 years: consult a doctor

Other Information

• store at controlled room temperature

Inactive ingredients

aloe barbadensis (aloe vera) leaf juice, diazolidinyl urea, edetate disodium, eucalyptus oil, methylparaben, methyl salicylate, mineral oil, PPG-1 trideceth-6, propylene glycol, propylparaben, purified water, sodium acrylates copolymer, steareth-21, stearyl alcohol, tocopheryl acetate, trolamine, white petrolatum

PRINCIPAL DISPLAY PANEL

Select Brand Medicated Anti-Itch Cream

Maximum Relief

Topical Analgesic

Net wt 1 oz (28.3 g)

INGREDIENTS AND APPEARANCE

SELECT BRAND ANTI-ITCH 
menthol and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15127-721
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	.1 g  in 10 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	.1 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MINERAL OIL (UNII: T5L8T28FGP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EUCALYPTUS OIL (UNII: 2R04ONI662)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15127-721-01	1 in 1 CARTON	01/03/2014
1		28.3 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/03/2012

Labeler - Select Brand (043562370)

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

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	label(15127-721) , manufacture(15127-721) , pack(15127-721)