ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN- isopropyl alcohol liquid

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN by

Drug Labeling and Warnings

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN by is a Otc medication manufactured, distributed, or labeled by Home Smart Products, Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (by volume)

Isopropyl alcohol (50% concentrate)

PURPOSE

Purpose

topical antimicrobial

INDICATIONS & USAGE

Uses

• to decrease germs in minor cuts and scrapes
• helps relieve minor muscular aches due to exertion

WARNINGS

Warnings

For external use only

• flammable, keep away from fire and flame
• will produce serious gastric disturbances if taken internally

ASK DOCTOR

Ask a doctor before use if you havedeep puncture wounds or serious burns

DO NOT USE

When using this product

• do not get into eyes or mucous membranes
• use only in a well-ventilated area

STOP USE

Stop use and ask a doctor ifcondition persists or gets worse

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of an accidental ingestion, contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION

Directions

• apply to skin directly of with clean gauze, cotton or swab
• for rubbing apply liberally and rub with hands

SPL UNCLASSIFIED SECTION

Other information

• does not contain, nor is intended as a substitute for grain or ethyl alcohol
• keep bottle tightly closed

INACTIVE INGREDIENT

Inactive ingredient

Water, methyl salicylate, laneth-75, FD&C Blue #1, FD&C Yellow #5

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

HEALTH SMART ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

TOPICAL ANTIMICROBIAL

12 FL.OZ (354 mL)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52862-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	50 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL SALICYLATE (UNII: LAV5U5022Y)
PEG-75 LANOLIN (UNII: 09179OX7TB)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52862-023-03	119 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/18/2020
2	NDC: 52862-023-04	178 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/18/2020
3	NDC: 52862-023-06	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/18/2020
4	NDC: 52862-023-09	295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/18/2020
5	NDC: 52862-023-10	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/18/2020
6	NDC: 52862-023-11	414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/18/2020
7	NDC: 52862-023-12	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	06/18/2020

Labeler - Home Smart Products (161872676)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(52862-023)