CVS ITCH RELIEF- pramoxine hydrochloride and zinc acetate lotion

CVS Itch Relief by

Drug Labeling and Warnings

CVS Itch Relief by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

CVS Itch Relief

Drug Facts

Active Ingredient

Pramoxine HCl 1%

Zinc Acetate 0.1%

Purpose

External Analgesic

Skin Protectant

Use

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and poison sumac and other minor skin irritations.

Warnings

For external use only. Use only as directed. Avoid contact with eyes and mucous membranes, Ask doctor before using in children under 2 years of age.

Stop use and ask a doctor if 

condition worsens. Symptoms last for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

• Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth not more than 3 to 4 times daily as needed for comfort.
  
• Children under 2 yrs. of age: Consult a doctor before use.

Inactive Ingredient

• SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose,  Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water.

Other Information

• store at room temperature 15 o – 30 oC (59 o – 85 oF)

PRINCIPAL DISPLAY PANEL

CVS Health
Itch Relief
CLEAR SKIN PROTECTANT
6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CVS ITCH RELIEF 
pramoxine hydrochloride and zinc acetate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-400
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
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-400-96	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2008

Labeler - CVS Pharmacy (062312574)

Registrant - Humco Holding group, inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	analysis(69842-400) , manufacture(69842-400) , pack(69842-400) , label(69842-400)