CALAMINE- calamine 8%, zinc oxide 8% lotion

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts Active ingredient

Calamine 8%
Zinc Oxide 8%

Purpose

• Calamine 8%, Zinc Oxide 8%: Skin protectant

Uses

Dries the oozing and weeping of poison:
■ ivy
■ oak
■ sumac

Warnings

■ For external use only

■ Use only as directed

When using this product

■ do not get into eyes

Stop use and ask a doctor if

■ condition worsens
■ symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

■ Adults and children of 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and dry the area before application. Apply lotion 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° - 30°C (59° - 86°F)

Inactive ingredients

Avicel, bentonite magma, calcium hydroxide, carrageenan, glycerin, purified water, and xanthan gum.

Questions or comments?

(855)-280-1079

Principal Display Panel

NDC: 85786-703-06

DR. SIMI

Calamine Lotion

Calamine
Topical Suspension

Skin Protectant

Poison Ivy, Oak, and Sumac Drying Lotion

6 fl oz (177 mL)

WARNING: DO NOT USE IF TAMPER EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
customerservice@drsimi.com
www.drsimi.com

Immediate container labeling

INGREDIENTS AND APPEARANCE

CALAMINE 
calamine 8%, zinc oxide 8% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-703
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	80 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
CARRAGEENAN (UNII: 5C69YCD2YJ)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
BENTONITE (UNII: A3N5ZCN45C)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-703-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/06/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/06/2026

Labeler - Farmacias De Similares TX LLC (119489934)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	analysis(85786-703) , label(85786-703) , pack(85786-703) , manufacture(85786-703)