ISOPROPYL ALCOHOL 70 PERCENT WITH WINTERGREEN OIL- isopropyl alcohol liquid

Isopropyl Alcohol 70 Percent With Wintergreen Oil by

Drug Labeling and Warnings

Isopropyl Alcohol 70 Percent With Wintergreen Oil by is a Otc medication manufactured, distributed, or labeled by Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Isopropyl Alcohol 70% by volume

Purpose

First aid antiseptic

Use

First aid to help prevent the risk of infection in.

• minor cuts
  
• scrapes
  
• burns

Warnings

For external use only.

• Flammable, keep way from spark, heat and flame.
  
• Use in well ventilated area, fumes may be harmful.

Ask a doctor before use for

• deep wounds
  
• animal bites
  
• serious burns

When using this product

• do not get into eyes or mucous membranes.
  
• do not apply to irritated skin.

Stop use and ask a doctor if

excessive irritation of the skin develops.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

• apply freely and rub briskly with hands or towel.

Other Information

• does not contain ethyl or grain alcohol and is not sold as a substitute for preparations containing the same.
  
• Store at controlled room temperature
  
• will produce serious gastric disturbances if taken internally.

Inactive Ingredient

Methyl salicylate 0.5%

FDC Blue #1

FDC Yellow #5

purified water

Good Neighbor Label

Sunmark Label

INGREDIENTS AND APPEARANCE

ISOPROPYL ALCOHOL 70 PERCENT WITH WINTERGREEN OIL 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82645-915
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	700 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82645-915-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	01/01/2016

Labeler - Pharma Nobis, LLC (118564114)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	analysis(82645-915) , manufacture(82645-915) , pack(82645-915) , label(82645-915)