PREMIERE VALUE CALAMINE- calamine 8% and zinc oxide 8% lotion

Premiere Value Calamine by

Drug Labeling and Warnings

Premiere Value Calamine by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

active Ingredients

Calamine 8%

Zinc Oxide 8%

Purpose

Skin Protectant

Skin Protectant

Uses

Dries the oozing and weeping of poison ivy, poison oak, and poison sumac and other skin irritations.

Warnings

For external use only. Use only as directed.

Avoid contat with eyes and moucous membranes.

Ask a doctor

before using on children under 6 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 6 mo. of age and older: Shake well before using. Cleanse the skin with soap and water. Let dry before each use. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort.

Children under 6 mo. of age: Consult a doctor before use.

Other information

Store at room temperature 15-30C (59-86F)

Inactive Ingredients

Bentonite Magma, Calcium Hydroxide, Glycerin, and Purified Water.

Questions or Comments?

Label

INGREDIENTS AND APPEARANCE

PREMIERE VALUE CALAMINE 
calamine 8% and zinc oxide 8% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	160 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
CALCIUM HYDRIDE (UNII: WY779SQ0XW)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-413-96	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/27/2017

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

Labeler - Chain Drug Consortium (101668460)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(68016-413) , analysis(68016-413) , pack(68016-413) , label(68016-413)