CALAMINE PHENOLATED TOPICAL SUSPENSION- calamine and zinc oxide and phenol lotion

Calamine Phenolated Topical Suspension by

Drug Labeling and Warnings

Calamine Phenolated Topical Suspension by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Calamine 8%

Purpose

Skin Protectant

Active Ingredient

Zinc Oxide 8%

Purpose

Skin Protectant

Active Ingredient

Liquefied Phenol 1%

Purpose

Topical Analgesic

Uses

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

Warnings

• For external use only. Use only as directed.
• Avoid contact with eyes and mucous membranes.
• Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas.
• If applied to fingers or toes do not bandage.

Ask a doctor

before using on children under 2 years of age.

When using this product. Discontinue use if condition worsen or does not improve within 7 days and consult a doctor.

Keep out of reach of children.

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

directions (Shake well before using)

Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often as needed for comfort.

Children under 2 years of age: Consult a doctor before use.

Other Information.

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

Inactive Ingredients.

Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water.

Principal Display Panel

INGREDIENTS AND APPEARANCE

CALAMINE PHENOLATED TOPICAL SUSPENSION 
calamine and zinc oxide and phenol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-0407
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
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-0407-96	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/25/1998

Labeler - Humco Holding Group, Inc (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(0395-0407) , pack(0395-0407) , analysis(0395-0407) , label(0395-0407)