BEST CHOICE MEDICATED ANTI ITCH- pramoxine hydrochloride, menthol cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
valu merchandisers
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
for the 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 Topical anagesic
Authorization status:
OTC monograph not final
Authorization number:
63941-265-01

BEST CHOICE MEDICATED ANTI ITCH- pramoxine hydrochloride, menthol cream

valu merchandisers

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Best Choice Medicated Anti itch Cream

Active Ingredient

Menthol 1%

Pramoxine hydrochloride 1%

Us es

for the 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

Purpos e

Topical anagesic

Warnings

When using this product

do not get into eyes

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Other Information

store at controlled room temperature

Directions

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

children under 2 years: consult a doctor

Adults and Children 2 years and older: Apply to affected are not more than 3 to 4 times daily.

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

package principal panel

Health Best Choice Care

Maximum Relief with Aloe and Vitamin E

Relieves Pain and Itch Fast

Steroid Free- Hydrocortisone Free

BEST CHOICE MEDICATED ANTI ITCH

pramoxine hydrochloride, menthol cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 39 41-26 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PRAMO XINE HYDRO CHLO RIDE (UNII: 8 8 AYB8 6 7L5) (PRAMOXINE -

UNII:0 6 8 X8 4E0 56 )

PRAMOXINE

HYDROCHLORIDE

in 10 0 g

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

in 10 0 g

valu merchandisers

Inactive Ingredients

Ingredient Name

Stre ng th

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

STEARETH-2 1 (UNII: 53J3F32P58 )

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

SO DIUM PO LYACRYLATE ( 8 0 0 0 MW) (UNII: 28 5CYO341L)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

METHYL SALICYLATE (UNII: LAV5U50 22Y)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

WATER (UNII: 0 59 QF0 KO0 R)

PETRO LATUM (UNII: 4T6 H12BN9 U)

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 39 41-26 5-0 1

1 in 1 CARTON

0 4/13/20 14

1

28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 4/13/20 14

Labeler -

valu merchandisers (868703513)

Registrant -

Weeks and Leo, Inc. (005290028)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Weeks & Leo , Inc.

0 0 529 0 0 28

ma nufa c ture (6 39 41-26 5)

Revised: 12/2019

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