ANTI ITCH SOOTHING 1 PRAMOXINE HYDROCHLORIDE- pramoxine hydrochloride spray 
The Honey Pot Company LLC

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.

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Anti–Itch Soothing Spray 1 % Pramoxine Hydrochloride

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:

Adults and children 12 years of age and older: Apply to affected not more than 3 or 4 times daily.

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:

Outer PackageInner Package

ANTI ITCH SOOTHING 1 PRAMOXINE HYDROCHLORIDE 
pramoxine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82637-9370
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82637-9370-11 in 1 CARTON03/01/2022
180 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2022
Labeler - The Honey Pot Company LLC (045600502)

Revised: 4/2023
Document Id: fa2ec451-5fcc-1dea-e053-6294a90a0288
Set id: 8bfeea34-25d5-4721-a17f-d9f1d0084cc3
Version: 3
Effective Time: 20230425
 
The Honey Pot Company LLC