ANTI ITCH SOOTHING 1 PRAMOXINE HYDROCHLORIDE- pramoxine hydrochloride spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

The Honey Pot Company LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For the temporary relief of pain and itching associated with minor skin irritations

Authorization status:

OTC monograph not final

Summary of Product characteristics

ANTI ITCH SOOTHING 1 PRAMOXINE HYDROCHLORIDE- PRAMOXINE
HYDROCHLORIDE SPRAY
THE HONEY POT COMPANY LLC
----------
_DRUG FACTS_
_ACTIVE INGREDIENT:_
Pramoxine HCl 1%
_PURPOSE:_
External Analgesic
_USES:_
For the temporary relief of pain and itching associated with minor
skin irritations
_WARNINGS:_
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT:
avoid contact with eyes.
STOP USE AND ASK DOCTOR IF:
Condition worsens
If symptoms persist for more than 7 days, or clear up and reoccur
again within a few
days
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away
_DIRECTIONS:_
Apply to affected not more than 3 or 4 times daily. ADULTS AND
CHILDREN 12 YEARS OF
AGE AND OLDER:
CHILDREN UNDER 12 YEARS OF AGE: CONSULT A DOCTOR
_INACTIVE INGREDIENTS:_
Water, Polysorbate 20, Glycerin, Pentylene Glycol, Hamamelis
virginiana (Witch Hazel)
Water, Benzoic Acid, Fragrance, Honey, Vinegar, Aloe Barbadensis Leaf
Juice, Sodium
Hydroxide, Cucumis Sativus (Cucumber) Fruit Extract, Lavender
(Lavandula Angutifolia)
Extract, Calendula Officinalis (Calendula) Flower Extract, Cocos
Nucifera (Coconut) Fruit
Extract, Allium Sativum (Garlic) Extract, Olea Europaea (Olive) Leaf
Extract, Potassium
Sorbate, Sodium Benzoate, Citric Acid
_OTHER INFORMATION:_
Store at a controlled room temperature 77°F (20-25°C).
QUESTIONS:
For questions and general information visit us at
www.thehoneypot.co/contact
PACKAGE LABELING:
ANTI ITCH SOOTHING 1 PRAMOXINE HYDROCHLORIDE
pramoxine hydrochloride spray
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:82637-9370
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE -
UNII:068X84E056)
PRAMOXINE
HYDROCHLORIDE
10 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: