HEALTH CARE CALAMINE- calamine 8% and zinc oxide 8% lotion

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

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Ladda ner Produktens egenskaper (SPC)
20-12-2023

Aktiva substanser:

Calamine 8%, Zinc Oxide 8%

Tillgänglig från:

Great Lakes Wholesale, Marketing and Sales Inc

Administreringssätt:

TOPICAL

Receptbelagda typ:

OTC DRUG

Terapeutiska indikationer:

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

Bemyndigande status:

OTC monograph final

Produktens egenskaper

                                HEALTH CARE CALAMINE- CALAMINE 8% AND ZINC OXIDE 8% LOTION
GREAT LAKES WHOLESALE, MARKETING AND SALES INC
----------
HEALTH CARE CALAMINE LOTION
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
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
NEW LABEL
HEALTH CARE CALAMINE
calamine 8% and zinc oxide 8% lotion
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:64092-413
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:64092-
413-96
177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
10/27/2017
MARKETING INFORMATION
Great La
                                
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