CALAMINE- calamine 8% and zinc oxide 8% lotion

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Calamine 8% and Zinc Oxide 8%

Disponibil de la:

Pierson Laboratories

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

OTC DRUG

Indicații terapeutice:

Skin protectant dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

Statutul autorizaţiei:

OTC monograph final

Caracteristicilor produsului

CALAMINE- CALAMINE 8% AND ZINC OXIDE 8% LOTION
PIERSON LABORATORIES
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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CALAMINE LOTION
Drug Facts
ACTIVE INGREDIENTS
Calamine 8% and Zinc Oxide 8%
PURPOS E
Skin protectant
US ES
dries the oozing and weeping o 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 chilren 6 months of age.
WHEN USING THIS PRODUCT
Discontinue use if condition worsens 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
Adults and chidren 2 years of age and older: shake well before using.
Cleanse the skin with soap and
water and let it dry befroe each use. Apply lotion to the affected
area using a cotton or soft cloth, as
often as needed for comfort.
Children under 6 months of age: Consult a doctor before use.
OTHER INFORMATION
Store at room temperature 13-30C (50-86F)
INACTIVE INGREDIENTS
Bentonite magma, calcium hydroxide, glycerin, purified water.
LABEL
CALAMINE
calamine 8% and zinc oxide 8% lotion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:4559 1-0 41
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)
ZINC CATION
16 0 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
BENTO NITE (UNII: A3N5ZCN45C)
CARRAGEENAN (UNII: 5C6 9 YCD2YJ)
XANTHAN GUM (UNII: TTV12P4NEE)
Pierson Laboratories
CALCIUM HYDRO XIDE (UNII: PF5DZW74VN)
GLYCERIN (UNII: PDC6 A3C0 OX)
WATER (UNII: 0 59 QF0 KO0 R)
MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETIN