FREDS 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:
Weeks and Leo, Inc.
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:
11383-265-01

FREDS MEDICATED ANTI ITCH- pramoxine hydrochloride, menthol cream

Weeks and Leo, Inc.

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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Armand 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

Medicated anti- itch Cream

Topical analgesic

Maximum strength pain and Itch relief

FREDS MEDICATED ANTI ITCH

pramoxine hydrochloride, menthol cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:1138 3-26 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

Weeks and Leo, Inc.

Inactive Ingredients

Ingredient Name

Stre ng th

STEARETH-2 1 (UNII: 53J3F32P58 )

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

SO DIUM ACRYLATE (UNII: 7C9 8 FKB43H)

MINERAL O IL (UNII: T5L8 T28 FGP)

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)

PPG-1 TRIDECETH-6 (UNII: 1K7417JX6 Q)

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

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:1138 3-26 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 -

Weeks and Leo, Inc. (005290028)

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 (1138 3-26 5)

Revised: 4/2019

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