70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN

AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN by

Drug Labeling and Warnings

AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN by is a Otc medication manufactured, distributed, or labeled by New Pride Corp, Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN- isopropyl alcohol liquid 
New Pride Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN

Active ingredient (by volume)

Isopropyl alcohol (70% concentrate)

Purpose

topical antimicrobial

Uses

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

Warnings

For external use only

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

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

When using this product

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

Stop use and ask a doctor if condition persists or gets worse

Keep out of reach of children.

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

Directions

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

Other information

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

Inactive ingredient

Water, Methyl Salicylate, FD&C Blue #1, FD&C Yellow #5

PRINCIPAL DISPLAY PANEL

AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58037-006
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL SALICYLATE (UNII: LAV5U5022Y)
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: 58037-006-01	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/05/2023	01/13/2023
2	NDC: 58037-006-02	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/05/2023	01/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/05/2023	01/13/2023

Labeler - New Pride Corp (884264198)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(58037-006)

Revised: 1/2023

Document Id: f25caf26-4f25-c7bb-e053-2a95a90a9096

34390-5

Set id: f15a6843-78aa-223c-e053-2a95a90a2033

Version: 3

Effective Time: 20230116