CVS CALAMINE PLUS- zinc oxide lotion

CVS Calamine Plus by

Drug Labeling and Warnings

CVS Calamine Plus 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 Calamine Plus

Drug Facts

Active Ingredient

Calamine 8%

Active Ingredient

Pramoxine HCl 1%

Purpose

Skin Protectant

Purpose

External Analgesic

Use

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

Warnings

For external use only. Use only as directed.

When using this product avoid contact with eyes.

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.

Other Information

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

Inactive Ingredient

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

PRINCIPAL DISPLAY PANEL

Calamine
Plus
Itch Relief
6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CVS CALAMINE PLUS 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (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: 69842-420-96	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(69842-420) , manufacture(69842-420) , pack(69842-420) , label(69842-420)