Shine and Clean Hand Sanitizer Gel

SHINE AND CLEAN HAND SANITIZER- alcohol gel Maquiladora Miniara S.A de C.V.Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Shine and Clean Hand Sanitizer Gel

Drug facts

Active ingredientEthyl alcohol 70%

PurposeAntiseptic

Usesto decrease bacteria on the skin that could cause diseaserecommended for repeated use

WarningsFor external use only: handsFlammable. Keep away from heat and flame.

When us ing this productkeep out of eyes. In case of contact with eyes, flush thoroughly with water.avoid contact with broken skindo not inhale or ingest

Stop use and ask a doctor ifirritation or redness developscondition persists for more than 72 hours

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

Directionswet hands thoroughly with product and allow to dry without wipingfor children under 6, use only under adult supervisionnot recommender for infants

Other informationdo not store above 105°Fmay discolor some fabricsharmful to wood finishes and plastics

Inactive ingredientswater, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30alkyl acrylate crosspolymer, benzophenone-4

Package Labeling:

Package Labeling 3.785L

1000L Package Label

SHINE AND CLEAN HAND SANITIZER alcohol gel

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:76 753-0 0 1

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 0 .7 mL in 1 mL

Inactive IngredientsIngredient Name Strength

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERYL MO NO CAPRYLO CAPRATE (UNII: G7515SW10 N)

GLYCERIN (UNII: PDC6 A3C0 OX)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

SULISO BENZO NE (UNII: 1W6 L6 29 B4K)

Packaging

# Item Code Package Description Marketing StartDate Marketing End Date

1 NDC:76 753-0 0 1-0 1 10 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 4/10 /20 20

2 NDC:76 753-0 0 1-0 2

10 0 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio nPro duct 0 4/10 /20 20

3 NDC:76 753-0 0 1-0 3 378 5 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 4/10 /20 20

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph no t fina l part333E 0 4/10 /20 20

Maquiladora Miniara S.A de C.V.

Labeler - Maquiladora Miniara S.A de C.V. (812802434)

EstablishmentName Addre ss ID/FEI Bus ine ss Ope rations

Maquilado ra Miniara S.A de C.V. 8 128 0 2434 manufacture(76 753-0 0 1)

Revised: 6/2020