Select Brand Anti-Itch

Set ID
0bacd190-b118-0df3-e054-00144ff8d46c
Manufacturer
Select Brand | Weeks & Leo Co., Inc.
Effective date
2015-01-12
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 22:41:20

Key Label Information

Active Ingredients And Purpose

Active ingredients

Menthol 1% Pramoxine hydrochloride 1%

Purpose

Topical analgesic

Uses

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

Warnings

For external use only

Directions And Dosage

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 Label Information

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)

Products

NDC Codes

Ingredients

NameUNIIKind
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
METHYL SALICYLATELAV5U5022YIACT
SODIUM ACRYLATE7C98FKB43HIACT
EDETATE DISODIUM7FLD91C86KIACT
METHYLPARABENA2I8C7HI9TIACT
PPG-1 TRIDECETH-61K7417JX6QIACT
STEARYL ALCOHOL2KR89I4H1YIACT
ALOE VERA LEAFZY81Z83H0XIACT
MINERAL OILT5L8T28FGPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EUCALYPTUS OIL2R04ONI662IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
TROLAMINE9O3K93S3TKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PETROLATUM4T6H12BN9UIACT

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 1% Pramoxine hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

store at controlled room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Select Brand Medicated Anti-Itch Cream Maximum Relief Topical Analgesic Net wt 1 oz (28.3 g)

Source Document

Official SPL XML cached by FDA.report ยท DailyMed PDF

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XML SHA-256
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XML bytes
25647

Legacy File Index

FolderFileDate
otc0bacd190-b119-0df3-e054-00144ff8d46c.xml2015-01-13
otcSB_Med_Crm_Back_Box.jpg2015-01-13
otcSB_Med_Crm_Box_Front.jpg2015-01-13