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NDC 10107-0429-02 Herb Street Anti-Itch Stick 0.01 g/g Details

Herb Street Anti-Itch Stick 0.01 g/g

Herb Street Anti-Itch Stick is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by Balassa Laboratories Inc.. The primary component is HYDROCORTISONE.

Product Information

NDC	10107-0429
Product ID	10107-429_01709063-a8fb-410e-ba76-ad0d029fc9d0
Associated GPIs
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	Herb Street Anti-Itch Stick
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hydrocortisone
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	0.01
Active Ingredient Units	g/g
Substance Name	HYDROCORTISONE
Labeler Name	Balassa Laboratories Inc.
Pharmaceutical Class	Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10107-0429-02 (10107042902)

Pricing Information	N/A
NDC Package Code	10107-429-02
Billing NDC	10107042902
Package	1 TUBE in 1 CARTON (10107-429-02) / 16.8 g in 1 TUBE (10107-429-01)
Marketing Start Date	2022-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8717faae-59c3-4c6f-9ef1-285c0d2445ed Details

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

eczema
insect bites
poison ivy, poison oak, or poison sumac
seborrheic dermatitis
psoriasis
Other uses of this product should only be under the advice and supervision of a doctor.

Warnings

For external use only

Do not use

for the treatment of diaper rash. Consult a doctor.

When using this product

use only as directed
avoid contact with eyes

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
If you need to stop use of the product because of the above, do not begin use of any other hydrocortisone product unless you have consulted a doctor.

If pregnant or breast-feeding

ask a healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

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: do not use; consult a doctor.

Other Information

store at room temperature

Inactive Ingredients

avocado oil, yellow wax, castor oil, soybean oil, Cannabis Sativa seed oil, glycerol, phenoxyethanol, tocopheryl acetate, aloe vera leaf extract, ethylhexylglycerin

PRINCIPAL DISPLAY PANEL - 16.8 g Tube in Carton

Herb Street with Hemp Seed Oil Moisturizer

Anti-Itch Stick

1% Hydrocortisone

Topical Analgesic Stick

NET WT 0.59 oz (16.8 g)

No Mess Stick

Money Back Guranteed

Manufactured by Balassa Laboratories, Inc.

PO Box 291161, Port Orange, FL 32129

Made in the USA from US and Imported Materials

All copyrights and trademarks are owned by Balassa Laboratories, Inc.

INGREDIENTS AND APPEARANCE

HERB STREET ANTI-ITCH STICK

hydrocortisone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10107-429
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	.01 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
AVOCADO OIL (UNII: 6VNO72PFC1)
SOYBEAN OIL (UNII: 241ATL177A)
CASTOR OIL (UNII: D5340Y2I9G)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10107-429-02	1 in 1 CARTON	05/01/2022
1	NDC:10107-429-01	16.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/01/2022

Labeler - Balassa Laboratories Inc. (069162485)

Name	Address	ID/FEI	Business Operations
Establishment
Balassa Laboratories Inc.		069162485	manufacture(10107-429) , label(10107-429) , pack(10107-429)

Revised: 4/2022

Document Id: 01709063-a8fb-410e-ba76-ad0d029fc9d0

Set id: 8717faae-59c3-4c6f-9ef1-285c0d2445ed

Version: 1

Effective Time: 20220426

Search by Drug Name or NDC

NDC 10107-0429-02 Herb Street Anti-Itch Stick 0.01 g/g Details

Herb Street Anti-Itch Stick 0.01 g/g

Product Information

Package

Package Images

NDC 10107-0429-02 (10107042902)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 8717faae-59c3-4c6f-9ef1-285c0d2445ed Details

Drug Facts

Active Ingredient

Purpose

Uses

Warnings

Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding

Keep out of reach of children.

Directions

Other Information

Inactive Ingredients

PRINCIPAL DISPLAY PANEL - 16.8 g Tube in Carton

INGREDIENTS AND APPEARANCE

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Search by Drug Name or NDC

NDC 10107-0429-02 Herb Street Anti-Itch Stick 0.01 g/g Details

Herb Street Anti-Itch Stick 0.01 g/g

Product Information

Package

Package Images

NDC 10107-0429-02 (10107042902)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 8717faae-59c3-4c6f-9ef1-285c0d2445ed Details

Drug Facts

Active Ingredient

Purpose

Uses

Warnings

Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding

Keep out of reach of children.

Directions

Other Information

﻿Inactive Ingredients

PRINCIPAL DISPLAY PANEL - 16.8 g Tube in Carton

INGREDIENTS AND APPEARANCE

Inactive Ingredients