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NDC 41250-0093-34 Aloe Vera Gel 2.5 g/g Details

Aloe Vera Gel 2.5 g/g

Aloe Vera Gel is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	41250-0093
Product ID	41250-093_a377b091-402e-43fd-9e7e-4a51141d30b0
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	Aloe Vera Gel
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	2.5
Active Ingredient Units	g/g
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	Meijer Distribution
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 41250-0093-34 (41250009334)

Pricing Information	N/A
NDC Package Code	41250-093-34
Billing NDC	41250009334
Package	226 g in 1 BOTTLE, PLASTIC (41250-093-34)
Marketing Start Date	2016-08-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6079f808-2fc5-4397-825d-8fa7791ac4a3 Details

Active ingredient

Lidocaine HCl 0.5%

Purpose

External analgesic

Uses

for the temporary relief of pain and itching associated with

minor burns
sunburn
minor cuts
scrapes
insect bites
minor skin irritations

Warnings

For external use only

When using this product

avoid contact with the eyes

Do not use

in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

condition worsens, or if symptoms persist for 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

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

Inactive ingredients

water, propylene glycol, glycerin Aloe barbadensis leaf juice, triethanolamine, isopropyl alcohol, polysorbate 80, carbomer, phenoxyethanol, benzyl alcohol, menthol, disodium EDTA, blue 1, yellow 5

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Bayer, distributor of Solarcaine Cool Aloe Burn Relief Formula

Questions 1-888-593-0593

DIST BY MEIJER DISTRIBUTION, INC

GRAND RAPIDS, MI 49544

www. meijer.com

principal display panel

meijer

Sunburn Relief Aloe Vera Gel Pain Relieving Gel With Lidocaine

Compare to Solarcaine*

NET WT 8 OZ (226 g)

INGREDIENTS AND APPEARANCE

ALOE VERA GEL

lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-093
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2.5 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
MENTHOL (UNII: L7T10EIP3A)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-093-34	226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/29/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/29/2016

Labeler - Meijer Distribution (006959555)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(41250-093)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(41250-093)

Revised: 4/2022

Document Id: a377b091-402e-43fd-9e7e-4a51141d30b0

Set id: 6079f808-2fc5-4397-825d-8fa7791ac4a3

Version: 11

Effective Time: 20220413