Clear Itch Relief by Evora Worldwide / Inspec Solutions LLC Drug Facts

Clear Itch Relief by

Drug Labeling and Warnings

Clear Itch Relief by is a Otc medication manufactured, distributed, or labeled by Evora Worldwide, Inspec Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLEAR ITCH RELIEF EVORA LABS- pramoxine hcl, zinc acetate spray 
Evora Worldwide

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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Drug Facts

Active ingredients                               Purpose

Pramoxine HCl                                    Topical analgesic

Zinc Acetate                                        Skin protectant

Uses

Temporanly relieves pain and itching associated with:

rashes due to poison ivy, poison oak or poison sumac
insect bites
minor skin irritation
minor cuts
dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings
For external use only

Flammable: Do not use while smoking or near heat or flame
Stop use and ask doctor if condition worsens or does not improve within 7 days symptoms persist for more than 7 days or clear up and
occur again with 1n a few days

When using this product keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents are under pressure. Do not store at temparatures above 1200F.

Keep out or reach or children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

shake well before use adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor

Inactive inaredients

Avena sativa (OatMeal) Extract, Camphor, Citric Acid, Diazolidinyl Urea, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben,
Polysorbate 40, Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Water

Questions?

1-888-793-8450

CLEAR ITCH RELIEF  EVORA LABS
pramoxine hcl, zinc acetate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77375-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OATMEAL (UNII: 8PI54V663Y)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 40 (UNII: STI11B5A2X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALCOHOL (UNII: 3K9958V90M)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77375-004-02	85 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2020	12/31/2020

Labeler - Evora Worldwide (081336028)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC		081030372	manufacture(77375-004)

Revised: 12/2020

Document Id: b6fb65df-5e7d-cfb4-e053-2a95a90a6226

34390-5

Set id: cbbc076e-14ec-4604-af80-f03092773652

Version: 3

Effective Time: 20201221