LOT- citric acid liquid 
Aurelio Muñoz Sagaón

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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Inactive Ingredients

ammonium carbonate, glycerin, water.

Active ingredients

Citric acid 0.15% Purpose: Antiseptic

Ascorbic acid 0.21% Purpose: Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame.

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Do not use

In children less than 2 months of age

On open skin wounds

When using this product

keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly

with water.

Ask a doctor

If irritation or rash occurs. This may be a sign of a serious condition.

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

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years old of age when using this product to avoid swallowing.

Purpose

Purpose: Antiseptic

Package label- Principal Display Panel

1000 mL NDC: 78746-002-01

Lot

LOT 
citric acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78746-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 98.75 g  in 100 g
AMMONIUM CARBONATE (UNII: NJ5VT0FKLJ) 0.1 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 1 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78746-002-011000 g in 1 BOTTLE; Type 0: Not a Combination Product06/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/06/2020
Labeler - Aurelio Muñoz Sagaón (951578972)
Registrant - Aurelio Muñoz Sagaón (951578972)
Establishment
NameAddressID/FEIBusiness Operations
Aurelio Muñoz Sagaón951578972manufacture(78746-002)

Revised: 6/2020
Document Id: a76eff58-1291-0d7e-e053-2a95a90a0b15
Set id: a76eff58-1290-0d7e-e053-2a95a90a0b15
Version: 1
Effective Time: 20200606
 
Aurelio Muñoz Sagaón