GO PSP CALAMINE- zinc carbonate, zinc oxide suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC CARBONATE (UNII: EQR32Y7H0M) (ZINC CATION - UNII:13S1S8SF37), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)

Available from:

RW Consumer Products Ltd

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

• dries the oozing and weeping of poison • ivy • oak • sumac

Authorization status:

OTC monograph final

Summary of Product characteristics

GO PSP CALAMINE- ZINC CARBONATE, ZINC OXIDE SUSPENSION
RW CONSUMER PRODUCTS LTD
_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._
----------
GO PSP CALAMINE LOTION
_DRUG FACTS_
_ACTIVE INGREDIENT_
Calamine 7.6%
Zinc oxide 7.6%
_PURPOSE_
Poison ivy, oak sumac drying
_USE_
• dries the oozing and weeping of poison • ivy • oak • sumac
_WARNINGS_
FOR EXTERNAL USE ONLY.
WHEN USING THIS PRODUCT
do not get into eyes
STOP USE AND ASK A DOCTOR IF
Conditions worsens
Symptoms last more than 7 days or clear up and occur again within a
few days
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
Shake well before using
Apply as needed
_OTHER INFORMATION_
Store at 59°- 86°F
Do not use if induction seal under cap is broken or missing
_INACTIVE INGREDIENTS_
bentonite magma, calcium hydroxide, glycerin, purified water
PACKAGE LABELING:
GO PSP CALAMINE
zinc carbonate, zinc oxide suspension
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:69612-010
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ZINC CARBONATE (UNII: EQR32Y7H0M) (ZINC CATION - UNII:13S1S8SF37)
ZINC CATION
76 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
ZINC CATION
76 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
RW Consumer Products Ltd
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:69612-
010-01
1 in 1 BOX
10/01/2021
1
100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
part347
10/01/2021
LABELER -
RW Con