HARRIS TEETER CALAMINE- zinc oxide liquid

Harris Teeter Calamine by

Drug Labeling and Warnings

Harris Teeter Calamine by is a Otc medication manufactured, distributed, or labeled by Harris Teeter, LLC., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Harris Teeter Calamine Lotion

Drug Facts

Active Ingredient

Calamine 8%

Active Ingredient

Zinc Oxide 8%

Purpose

Skin Protectant

Uses

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

Warnings

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using on children

When using this product.

Discontinue use if condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few 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

• Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, as often as needed.
• Children under 6 months of age: Consult a doctor before use.

Other Information

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

Inactive Ingredients

Avicel, Bentonite Magma, Calcium Hydroxide, Carrageenan, Glycerin, Purified Water, and Xanthan Gum.

Label

INGREDIENTS AND APPEARANCE

HARRIS TEETER CALAMINE 
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69256-413
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
BENTONITE (UNII: A3N5ZCN45C)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
CARRAGEENAN (UNII: 5C69YCD2YJ)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69256-413-96	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/26/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/26/2017

Labeler - Harris Teeter, LLC. (048463103)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(69256-413) , analysis(69256-413) , pack(69256-413) , label(69256-413)