B CLEAN HAND SANITIZER: Package Insert and Label Information

B CLEAN HAND SANITIZER- alcohol gel
AGE DO BRASIL INDUSTRIA E COMERCIO LTDA.

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.

Active Ingredient


Ethyl Alcohol 70% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use


Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

Warnings

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

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.


Stop use and aks a doctor if irritation or rash occurs. These may be signs of a serious condition.


Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 59º-86ºF (15º-30ºC)
  • Avoid freezing and excessive heat above 104ºF (40ºC)
  • May discolor certains fabrics

Inactive Ingredients


Aqua, Carbomer, Denatonium Benzoate, Isopropanolamine, Mentha Piperita Extract, Propylene Glycol, Salvia Officinalis Leaf Extract, Verbena Officinalis Leaf Extract

Package Label — Principal Display Panel

HAND SANITIZER
ALCOHOL-BASED GEL
moisturizing Net wt. 15.52 oz (440g)

440g
(click image for full-size original)

Manufactured by: Age do
Brasil Ind. e Com. LTDA.
Vinhedo SP
CEP 13288-169
Brazil

Distributed by: Heth LLC
1390 Brickell Ave
Miami FL 33131
+1 844 989 311 MADE IN BRAZIL

Warning! Flammable liquid and vapor

NDC -- 78069-001-01
(click image for full-size original)
NDC -- 78069-001-02
(click image for full-size original)

B CLEAN HAND SANITIZER ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78069-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 308 g in 440 g
Inactive Ingredients
Ingredient Name Strength
WATER 127.01876 g in 440 g
PROPYLENE GLYCOL 2.2 g in 440 g
ISOPROPANOLAMINE 0.4488 g in 440 g
VERBENA OFFICINALIS LEAF 0.044 g in 440 g
SAGE 0.044 g in 440 g
DENATONIUM BENZOATE 0.00044 g in 440 g
MENTHA PIPERITA 0.044 g in 440 g
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE 2.2 g in 440 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78069-001-01 440 g in 1 BOTTLE None
2 NDC:78069-001-02 440 g in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/30/2020
Labeler — AGE DO BRASIL INDUSTRIA E COMERCIO LTDA. (920307841)
Establishment
Name Address ID/FEI Operations
AGE DO BRASIL INDUSTRIA E COMERCIO LTDA. 920307841 manufacture (78069-001)

Revised: 05/2020 AGE DO BRASIL INDUSTRIA E COMERCIO LTDA.

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