Search by Drug Name or NDC

NDC 76473-0103-01 Brittanies Thyme Lavender and Peppermint Hand Sanitizer 0.62 mL/mL Details

Brittanies Thyme Lavender and Peppermint Hand Sanitizer 0.62 mL/mL

Brittanies Thyme Lavender and Peppermint Hand Sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Gulf States International, Inc. The primary component is ALCOHOL.

Product Information

NDC	76473-0103
Product ID	76473-103_e572cb0a-bd97-a202-e053-2a95a90a78a3
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	Brittanies Thyme Lavender and Peppermint Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.62
Active Ingredient Units	mL/mL
Substance Name	ALCOHOL
Labeler Name	Gulf States International, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 76473-0103-01 (76473010301)

Pricing Information	N/A
NDC Package Code	76473-103-01
Billing NDC	76473010301
Package	59 mL in 1 BOTTLE, SPRAY (76473-103-01)
Marketing Start Date	2020-07-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c7d0866d-595f-415d-bebe-8e4d1338405e Details

DRUG FACTS

SPL UNCLASSIFIED SECTION

Organic Ethyl Alcohol 62%

Antiseptic

Uses:

To help reduce bacteria on the skin.

Warning

For External Use Only

Flammable, Keep away from fire or source of ignition.

When using this product,

keep out of eyes. In case of eye contact, flush thoroughly with water.

Stop use and ask a doctor

if irritation and redness develops and persists for more than 72 hours.

Keep out of reach of children.

If swallowed get medical attention or contact a poison control center immediately.

Other Information:

Store at room temperature 66°F to 77°F (20°C to 25°C) May discolor certain fabrics.

Directions:

Wet hands thoroughly and allow to air dry. For children under 6, use adult supervison. Not recommended for infants.

Inactive Ingredients:

Purified Water, *Aloe Leaf Juice, *Peppermint Oil, Lavender Oil, Glycerin and Vitamin E

*USDA Certified Organic

Package Labeling:

INGREDIENTS AND APPEARANCE

BRITTANIES THYME LAVENDER AND PEPPERMINT HAND SANITIZER

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76473-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEPPERMINT OIL (UNII: AV092KU4JH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76473-103-01	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/21/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/21/2020

Labeler - Gulf States International, Inc (008156853)

Revised: 8/2022

Document Id: e572cb0a-bd97-a202-e053-2a95a90a78a3

Set id: c7d0866d-595f-415d-bebe-8e4d1338405e

Version: 2

Effective Time: 20220804