CLEAR ITCH RELIEF- pramoxine hcl, zinc acetate spray

Clear Itch Relief by

Drug Labeling and Warnings

Clear Itch Relief by is a Otc medication manufactured, distributed, or labeled by TopCare, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                                                   Purpose
Pramoxine HCI 1.0%...............................................Topical analgesic
Zinc Acetate 0.1%.....................................................Skin protectant

Purpose

Uses

• Temporarily relieves pain and itching asociated 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 near heat, flame, or while smoking.

​​​

When using this product

• keep out of eyes. Rinse with water to remove.
• Do not puncture or incinerate. Contents under pressure. Do no store at temperatures above 120F.

Stop use and ask a 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 in a few days.

Keep out of reach of children

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

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 ingredients

Avena Sativa (Oat) Meal Extract,
Camphor, Citric Acid, Diazolidinyl Urea, Fragrance, Glycerin,
Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 40,
Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Water.
CLEAR SKIN PROTECTANT
Pramoxine HCl 1% - Topical Analgesic
Zinc Acetate 0.1% - Skin Protectant
Drying Action PLUS Itch Relief
Continuous Spray
Relieves Pain And Itch
Associated Wit

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEAR ITCH RELIEF 
pramoxine hcl, zinc acetate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-874
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 ACETATE	.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
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)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-874-03	85 g in 1 CAN; Type 0: Not a Combination Product	01/22/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/22/2013

Labeler - TopCare (006935977)

Registrant - Product Quest Mfg, LLC (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(36800-874) , label(36800-874)