ANTI ITCH SOOTHING 1 PRAMOXINE HYDROCHLORIDE- pramoxine hydrochloride spray

Anti Itch Soothing 1 Pramoxine Hydrochloride by

Drug Labeling and Warnings

Anti Itch Soothing 1 Pramoxine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by The Honey Pot Company LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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: T7S323PKJS)
BENZOIC ACID (UNII: 8SKN0B0MIM)
HONEY (UNII: Y9H1V576FH)
ACETIC ACID (UNII: Q40Q9N063P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CUCUMBER (UNII: YY7C30VXJT)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
COCONUT (UNII: 3RT3536DHY)
GARLIC (UNII: V1V998DC17)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82637-9370-1	1 in 1 CARTON	03/01/2022
1		80 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/01/2022

Labeler - The Honey Pot Company LLC (045600502)