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NDC 36800-0218-30 Clear Anti Itch 10; 1 mg/mL; mg/mL Details

Clear Anti Itch 10; 1 mg/mL; mg/mL

Clear Anti Itch is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO ASSOCIATES. The primary component is PRAMOXINE HYDROCHLORIDE; ZINC ACETATE.

Product Information

NDC	36800-0218
Product ID	36800-218_131543cb-8203-4ba5-97c5-66e083ca15cd
Associated GPIs	90859902954120
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Clear Anti Itch
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pramoxine HCl, Zinc acetate
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	10; 1
Active Ingredient Units	mg/mL; mg/mL
Substance Name	PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Labeler Name	TOPCO ASSOCIATES
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0218-30 (36800021830)

Pricing Information	N/A
NDC Package Code	36800-218-30
Billing NDC	36800021830
Package	177 mL in 1 BOTTLE, PLASTIC (36800-218-30)
Marketing Start Date	2009-06-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8d3d1ff5-4868-495d-807c-e45aa2176f63 Details

Active Ingredients

Pramoxine HCl 1%

Zinc acetate 0.1%

Purpose

External analgesic

Skin protectant

Use

for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumac
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

condition 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 applying was affected are of skin

adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily

children under 2 years of age - ask a doctor

Other information

store at room temperature (59°-77°F)

Inactive ingredients

alcohol, benzoic acid, camphor, citric acid, fragrance, glycerin, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, polysorbate 40, Rosmarinus officinalis (rosemary) leaf oil, sodium citrate, water

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL60007

TOPCP VIJA0622 Questions? 1-888-423-0139

[email protected] www.topcarebrand.com

Visit here for more information: http:/topbrnds.com/4901jl

This product is not manufactured of distributed by Bausch Health US, LLC,

Distributer of Caladryl Clear Lotion

Quality Guaranteed

principal display panel

TopCare health

NDC 36800-218-30

COMPARE TO CALADRYL CLEAR LOTION ACTIVE INGREDIENTS

Clear Anti-Itch Lotion

EXTERNAL ANALGESIC / SKIN PROTECTANT

For Relief of Pain and Itching Due To:

Poison Ivy, Oak or Sumac
Insect Bites
Minor Skin Irritations

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CLEAR ANTI ITCH

pramoxine hcl, zinc acetate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-218
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
glycerin (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LAVENDER OIL (UNII: ZBP1YXW0H8)
POLYSORBATE 40 (UNII: STI11B5A2X)
ROSEMARY OIL (UNII: 8LGU7VM393)
sodium citrate (UNII: 1Q73Q2JULR)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-218-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/03/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/03/2009

Labeler - TOPCO ASSOCIATES (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(36800-218)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(36800-218)

Revised: 8/2022

Document Id: 131543cb-8203-4ba5-97c5-66e083ca15cd

Set id: 8d3d1ff5-4868-495d-807c-e45aa2176f63

Version: 17

Effective Time: 20220829