PRAMOXINE ITCH RELIEF- pramoxine hcl 1% cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)

Available from:

CVS

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

External Analgesic For the temporary relief of itching associated with minor skin irritations

Authorization status:

OTC monograph not final

Summary of Product characteristics

PRAMOXINE ITCH RELIEF- PRAMOXINE HCL 1% CREAM
CVS
_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._
----------
CVS ITCH RELIEF MOISTURIZING CREAM
Pramoxine Hydrochloride 1%
External Analgesic
For the temporary relief of itching associated with minor skin
irritations
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT, do not get into eyes
STOP USE AND ASK A DOCTOR IF
Condition worsens
symptoms persist for more than 7 days or clear up and occur again
within a few
days
DO NOT USE ON
deep or puncture wounds
animal bites
serious burns
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
immediately (1-800-
222-1222)
DIRECTIONS:
ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: apply to affected area
not more than
3 to 4 times daily
CHILDREN UNDER 2 YEARS OF AGE : consult a doctor
Aloe Vera, Behenic Acid, Cetearyl Alcohol, Cetyl Alcohol, Ceramide AP,
Ceramide EOP,
Ceramide NP, Cholesterol, Dimethicone, Disodium EDTA, Glycerin,
Glyceryl Stearate,
Isopropyl Palmitate, PEG 100 Stearate, Petrolatum, Phenoxyethanol,
Phystosphingosine,
Polyglyceryl- 6 Behenate, Polyglyceryl-10 Stearate, Potassium Sorbate,
Shea butter,
Sodium Cetearyl Sulfate, Sodium Levulinate, Stearic Acid,
Triethanolamine, Triethyl
Citrate, Water, Xanthan Gum
PRAMOXINE ITCH RELIEF
pramoxine hcl 1% cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:51316-141
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 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
CHOLE