Shine Hand Sanitizer: Package Insert and Label Information

SHINE HAND SANITIZER- alcohol gel
Zermat Internacional S.A. de C.V.

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.

Drug Facts

Active ingredient[s]

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use[s]

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

Warnings

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

Do not use

• 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 ask 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 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients:

Purified water, Isopropyl Alcohol, Glycerin, Fragrance, Carbomer, Aminomethyl Propanol, Blue No. 1 CI. 42090.
Topical product / Non-sterile product.

Package Labeling: 60ml

Label
(click image for full-size original)

Package Labeling: 195ml

Label2
(click image for full-size original)

Package Labeling: 500ml

Label3
(click image for full-size original)

SHINE HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15828-005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ISOPROPYL ALCOHOL
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
AMINOMETHYLPROPANOL
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15828-005-02 60 mL in 1 BOTTLE None
2 NDC:15828-005-06 195 mL in 1 BOTTLE None
3 NDC:15828-005-16 500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 05/22/2020
Labeler — Zermat Internacional S.A. de C.V. (812820712)

Revised: 11/2021 Zermat Internacional S.A. de C.V.

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