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NDC 68121-0002-01 PHARMACY PRESCRIPTION 70% ISOPROPYL ALCOHOL WITH WINTERGREEN 70 mL/100mL Details

PHARMACY PRESCRIPTION 70% ISOPROPYL ALCOHOL WITH WINTERGREEN 70 mL/100mL

PHARMACY PRESCRIPTION 70% ISOPROPYL ALCOHOL WITH WINTERGREEN is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by PATCOS COSMETICS (INDIA) PRIVATE LIMITED. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	68121-0002
Product ID	68121-002_3f6ba29c-4b2e-46af-b9fe-4292543b6b53
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	PHARMACY PRESCRIPTION 70% ISOPROPYL ALCOHOL WITH WINTERGREEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	PATCOS COSMETICS (INDIA) PRIVATE LIMITED
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2022-12-31

Package

Package Images

NDC 68121-0002-01 (68121000201)

Pricing Information	N/A
NDC Package Code	68121-002-01
Billing NDC	68121000201
Package	354.8 mL in 1 BOTTLE (68121-002-01)
Marketing Start Date	2020-12-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c62ea9b8-bdcd-49a3-87ed-27a95a8e517e Details

EXTRA INFORMATION ON FRONT LABEL :

FIRST AID AND ANTISEPTIC: Helps prevent the risk of infection in minor cuts, scrapes and burns
WARNING :Flammable,keep away from heat ,spark ,electrical fire or flame : Use only in well ventilated area .Fumes may be harmful
CAUTION : Do not point at self or others, product will squirt when squeezed

Active Ingredients

Isopropyl Alcohol 70%

Purpose

First Aid Antiseptic

Uses

First aid to help prevent the risk of infection in

Minor cuts
Scrapes
Burns

Warnings

For external use only

If taken internally serious gastric disturbances will result.

Flammable : keep away from fire or flame ,heat, spark ,electrical.

Ask a doctor before use for deep or puncture wounds, animal bites or serious burns.

When using this product : do not get into eyes ,do not inhale ,do not apply over large area of the body ,do not use longer than 1 week.

Stop use and ask a doctor if condition persist or get worse.

Keep out of reach of children

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

Caution –

Fumes can be acutely irritating to skin ,eyes and the respiratory system.
Do not apply to irritated skin or if excessive irritation develops.
Avoid getting into eyes or mucus membranes .Avoid inhaling this product.

SPL UNCLASSIFIED SECTION

Directions

Clean the affected area.
Apply a small amount of this product on the area 1 to 2 times daily.
May be covered with a sterile bandage.
If bandaged lets dry first.

Other Information

Does not contain ,nor is intended as a substitute for grain or ethyl alcohol.
Tamper Evident : Do not use if the under cap safety foil is broken or missing.

Inactive ingredients

Water ( Aqua)
Methyl Salicylate
Laneth -75
FD and C Blue #1
FD AND C YELLOW #5

Product Image

INGREDIENTS AND APPEARANCE

PHARMACY PRESCRIPTION 70% ISOPROPYL ALCOHOL WITH WINTERGREEN

isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68121-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
METHYL SALICYLATE (UNII: LAV5U5022Y)
LANETH-75 (UNII: QQ4C4Q56ST)
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:68121-002-01	354.8 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/30/2020

Labeler - PATCOS COSMETICS (INDIA) PRIVATE LIMITED (916169451)

Name	Address	ID/FEI	Business Operations
Establishment
PATCOS COSMETICS (INDIA) PRIVATE LIMITED		675973979	manufacture(68121-002)

Revised: 12/2020

Document Id: 3f6ba29c-4b2e-46af-b9fe-4292543b6b53

Set id: c62ea9b8-bdcd-49a3-87ed-27a95a8e517e

Version: 1

Effective Time: 20201207