HONEY POT- anti-itch soothing liquid 
Disposable Hygiene LLC dba Anthem

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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Disposable Hygiene Anti-itching Cream 80 mL

Active Ingredient(s)

Pramoxine hydrochloride 1% (w/w)

Purpose

External analgesic

Use

For 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 a 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 the affected area 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 Angustifolia) 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 of 77°F (20-25°C).

For questions and general information visit us at www.thehoneypot.co/contact

Package Label - Principal Display Panel

80 mL NDC: 71505-022-80

80 mL NDC: 71505-022-80

HONEY POT 
anti-itch soothing liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71505-022
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
ACETIC ACID (UNII: Q40Q9N063P)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GARLIC OIL (UNII: 4WG8U28833)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WITCH HAZEL (UNII: 101I4J0U34)  
HONEY (UNII: Y9H1V576FH)  
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)  
COCONUT OIL (UNII: Q9L0O73W7L)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71505-022-8080 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/15/2022
Labeler - Disposable Hygiene LLC dba Anthem (079848737)
Establishment
NameAddressID/FEIBusiness Operations
Disposable Hygiene LLC dba Anthem079848737manufacture(71505-022)

Revised: 2/2022
Document Id: ddc4f5ad-9ed8-cc1a-e053-2a95a90a8668
Set id: ddc4f5ad-9ed9-cc1a-e053-2a95a90a8668
Version: 1
Effective Time: 20220215
 
Disposable Hygiene LLC dba Anthem