Search by Drug Name or NDC

NDC 59062-4001-05 BabyGanics Alcohol-Free Foaming Hand Sanitizer Mandarin 0.12 mg/mL Details

BabyGanics Alcohol-Free Foaming Hand Sanitizer Mandarin 0.12 mg/mL

BabyGanics Alcohol-Free Foaming Hand Sanitizer Mandarin is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by KAS Direct LLC dba BabyGanics. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	59062-4001
Product ID	59062-4001_427299ed-b7e7-4216-aa56-65279a466482
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	BabyGanics Alcohol-Free Foaming Hand Sanitizer Mandarin
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.12
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	KAS Direct LLC dba BabyGanics
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59062-4001-05 (59062400105)

Pricing Information	N/A
NDC Package Code	59062-4001-5
Billing NDC	59062400105
Package	50 mL in 1 BOTTLE, PUMP (59062-4001-5)
Marketing Start Date	2022-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 19304d65-aee9-42dd-aea8-61a7b8c9beb6 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzalkonium chloride 0.12%

Purpose

Antimicrobial

Uses

for hand sanitizing to decrease bacteria on the skin
recommended for repeated use

Warnings

For external use only

When using this product avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develops, or if condition lasts for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

pump a small amount of foam into palm of hand
rub thoroughly over all surfaces of both hands
rub hands together briskly until dry

Inactive ingredients

water, propanediol, cocamidopropylamine oxide, cetrimonium chloride, pyrus malus (apple) fruit extract, aloe barbadensis leaf juice1, calendula officinalis flower extract1, chamomilla recutita (matricaria) flower extract1, olea europaea (olive) leaf extract1, glycerin, citric acid, caprylyl/capryl glucoside, citrus aurantium dulcis (orange) peel extract, citrus reticulata (mandarin orange) peel oil, triethyl citrate, citrus grandis (grapefruit) peel oil, glycine soya oil, tocopherol

1: Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic.

PRINCIPAL DISPLAY PANEL - 249 mL Bottle Label

babyganics®

alcohol-free foaming

hand sanitizer

mandarin

kills 99.9% of bacteria*

dermatologist tested

Discover which of our ingredients

are certified organic on the back panel.

8.45 FL OZ (249 mL)

1137403

PRINCIPAL DISPLAY PANEL - 249 mL Bottle Label

INGREDIENTS AND APPEARANCE

BABYGANICS ALCOHOL-FREE FOAMING HAND SANITIZER MANDARIN

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59062-4001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
APPLE (UNII: B423VGH5S9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
OLIVE OIL (UNII: 6UYK2W1W1E)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
ORANGE PEEL (UNII: TI9T76XD44)
MANDARIN OIL (UNII: NJO720F72R)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59062-4001-2	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2022
2	NDC:59062-4001-5	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2022
3	NDC:59062-4001-1	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2022
4	NDC:59062-4001-3	2 in 1 CARTON	06/01/2022
4	NDC:59062-4001-5	50 mL in 1 BOTTLE, PUMP; 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	part333E	06/01/2022

Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 6/2022

Document Id: 427299ed-b7e7-4216-aa56-65279a466482

Set id: 19304d65-aee9-42dd-aea8-61a7b8c9beb6

Version: 1

Effective Time: 20220610