70% ISOPROPYL ALCOHOL PE 1L- 70% isopropyl alcohol primal elements liquid 
Riviera Beverages, LLC

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.

----------

70% Isopropyl Alcohol 1 Liter

Active Ingredients

Isopropyl Alcohol 70.00% v/v First Aid Antiseptic

Uses:

Helps prevent the risk of infection due to minor cuts, scraps and burns.

Warnings:

For External Use Only

Flammable-

Keep away from fire, flames, heat, sparks,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 areas of the body, do not use longer than 1 week

Stop and ask a Doctor-

conditions 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 irratating to skin, eyes and respitory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into eyes or on mucous membranes. Avoid inhaling this product.

Directions-

Clean affected area- apply a small amount of this product on the area 1 to 3 times a day, may be covered with a sterile bandage, if bandaged, let dry first.

Other Information:

Does not contain nor is intented as a substitute for grain or ethyl alcohol.

Inactive Ingredients:

Water (USP)

Uses

To prevent risk of infection

PAckage LAbel

1 liter 12 pack tray

70% ISOPROPYL ALCOHOL PE 1L 
70% isopropyl alcohol primal elements liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79071-1001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 30 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79071-1001-21000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2020
Labeler - Riviera Beverages, LLC (021785705)
Registrant - Riviera Beverages, LLC (021785705)
Establishment
NameAddressID/FEIBusiness Operations
Riviera Beverages, LLC021785705manufacture(79071-1001)

Revised: 10/2020
Document Id: b1fa5911-139d-d29f-e053-2995a90acf75
Set id: b1fa5911-139c-d29f-e053-2995a90acf75
Version: 1
Effective Time: 20201018
 
Riviera Beverages, LLC