FREDS MEDICATED ANTI ITCH- pramoxine hydrochloride, menthol cream

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Tilgængelig fra:

Weeks and Leo, Inc.

Indgivelsesvej:

TOPICAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

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

Autorisation status:

OTC monograph not final

Produktets egenskaber

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._
----------
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
1 g
in 10 0 g
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
1 g
in 10 0 g
Weeks and Leo, Inc.
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
STEARETH-2 1 (UNII