ANTI-ITCH SOOTHING WIPES 1 PRAMOXINE HYDROCHLORIDE- pramoxine hydrochloride cloth

Anti-Itch Soothing Wipes 1 Pramoxine Hydrochloride by

Drug Labeling and Warnings

Anti-Itch Soothing Wipes 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 Hydrochloride 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 withing a few days

Keep out of reach of of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions:

Adults and children 12 years of age and older: 

Children under 12 years of age: Consult a doctor

• Apply to affected area not more than 3 or 4 times daily.

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, *Aloe Barbadensis Leaf Juice, Althaea officinalis Root Extract, Avena Sativa (Oat) Kernel Extract, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocos Nucifera (Coconut) Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Disodium Cocoamphodiacetate, Ethylhexylglycerin, Euterpe Oleracea Fruit Extract, Fragrance, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Helianthus Annuus (Sunflower) Seed Oil, *Honey, Lactobacillus, Lactobacillus Ferment, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polyglyceryl-4 Caprate, Punica Granatum Fruit Extract, Rosa Centifolia Flower Water, Sodium Chloride, Tetrasodium Glutamate Diacetate Tocopheryl Acetate, *Vinegar (Apple Cider), Water *Organic Ingredients

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 WIPES 1 PRAMOXINE HYDROCHLORIDE 
pramoxine hydrochloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82637-9363
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
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
OAT (UNII: Z6J799EAJK)
CHAMOMILE (UNII: FGL3685T2X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
COCONUT (UNII: 3RT3536DHY)
CUCUMBER (UNII: YY7C30VXJT)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACAI (UNII: 46AM2VJ0AW)
GLYCERIN (UNII: PDC6A3C0OX)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HONEY (UNII: Y9H1V576FH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)
POMEGRANATE (UNII: 56687D1Z4D)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ACETIC ACID (UNII: Q40Q9N063P)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82637-9363-1	30 in 1 POUCH	03/01/2022
1		2.8 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

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)