PUROMA Instant Foaming Hand Sanitizer without Fragrance by ZENITH MICRO CONTROL

PUROMA Instant Foaming Hand Sanitizer without Fragrance by

Drug Labeling and Warnings

PUROMA Instant Foaming Hand Sanitizer without Fragrance by is a Otc medication manufactured, distributed, or labeled by ZENITH MICRO CONTROL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PUROMA INSTANT FOAMING HAND SANITIZER WITHOUT FRAGRANCE- alcohol liquid 
ZENITH MICRO CONTROL

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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Drug Facts

Active ingredient

Alcohol 70% V/V

Purpose

Antimicrobial.

Uses

Hand Sanitizer to help reduce bacteria on skin.

Recommended for repeated use.

Warnings

Flammable. Keep away from fire or flame.
For external use only.
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children

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

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.
Children under 6 years of age should be supervised when using Puroma Hand Sanitizer.

Inactive ingredients

Water,Isopropyl Alcohol ,Glycerin, Isopropyl Myristate, Alpha.- Tocopherol Acetate , Caprylyl Glycol, Aloe Vera Leaf, Propylene Glycol, Coco-Caprylate , PEG-7 Glyceryl Cocoate, Glyceryl Oleate, PEG-12 Dimethicone (300 CST)

Other information

Store below 110°F (43°C).
May discolor certain fabrics or surfaces.

Product label

image description

PUROMA INSTANT FOAMING HAND SANITIZER WITHOUT FRAGRANCE 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80948-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80948-008-014 in 1 PACKAGE03/10/2021
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 80948-008-026 in 1 PACKAGE03/10/202104/12/2021
260 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 80948-008-0312 in 1 PACKAGE03/10/202104/12/2021
360 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 80948-008-0424 in 1 PACKAGE03/10/202104/12/2021
460 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC: 80948-008-0548 in 1 PACKAGE03/10/202104/12/2021
560 mL in 1 BOTTLE; Type 0: Not a Combination Product
6NDC: 80948-008-064 in 1 PACKAGE03/10/202104/12/2021
670 mL in 1 BOTTLE; Type 0: Not a Combination Product
7NDC: 80948-008-076 in 1 PACKAGE03/10/202104/12/2021
770 mL in 1 BOTTLE; Type 0: Not a Combination Product
8NDC: 80948-008-0812 in 1 PACKAGE03/10/202104/12/2021
870 mL in 1 BOTTLE; Type 0: Not a Combination Product
9NDC: 80948-008-0924 in 1 PACKAGE03/10/202104/12/2021
970 mL in 1 BOTTLE; Type 0: Not a Combination Product
10NDC: 80948-008-1048 in 1 PACKAGE03/10/202104/12/2021
1070 mL in 1 BOTTLE; Type 0: Not a Combination Product
11NDC: 80948-008-114 in 1 PACKAGE03/10/202104/12/2021
1180 mL in 1 BOTTLE; Type 0: Not a Combination Product
12NDC: 80948-008-126 in 1 PACKAGE03/10/202104/12/2021
1280 mL in 1 BOTTLE; Type 0: Not a Combination Product
13NDC: 80948-008-1312 in 1 PACKAGE03/10/202104/12/2021
1380 mL in 1 BOTTLE; Type 0: Not a Combination Product
14NDC: 80948-008-1424 in 1 PACKAGE03/10/202104/12/2021
1480 mL in 1 BOTTLE; Type 0: Not a Combination Product
15NDC: 80948-008-1548 in 1 PACKAGE03/10/202104/12/2021
1580 mL in 1 BOTTLE; Type 0: Not a Combination Product
16NDC: 80948-008-164 in 1 PACKAGE03/10/202104/12/2021
16100 mL in 1 BOTTLE; Type 0: Not a Combination Product
17NDC: 80948-008-176 in 1 PACKAGE03/10/202104/12/2021
17100 mL in 1 BOTTLE; Type 0: Not a Combination Product
18NDC: 80948-008-1812 in 1 PACKAGE03/10/202104/12/2021
18100 mL in 1 BOTTLE; Type 0: Not a Combination Product
19NDC: 80948-008-1924 in 1 PACKAGE03/10/202104/12/2021
19100 mL in 1 BOTTLE; Type 0: Not a Combination Product
20NDC: 80948-008-2048 in 1 PACKAGE03/10/202104/12/2021
20100 mL in 1 BOTTLE; Type 0: Not a Combination Product
21NDC: 80948-008-214 in 1 PACKAGE03/10/202104/12/2021
21150 mL in 1 BOTTLE; Type 0: Not a Combination Product
22NDC: 80948-008-226 in 1 PACKAGE03/10/202104/12/2021
22150 mL in 1 BOTTLE; Type 0: Not a Combination Product
23NDC: 80948-008-2312 in 1 PACKAGE03/10/202104/12/2021
23150 mL in 1 BOTTLE; Type 0: Not a Combination Product
24NDC: 80948-008-2424 in 1 PACKAGE03/10/202104/12/2021
24150 mL in 1 BOTTLE; Type 0: Not a Combination Product
25NDC: 80948-008-254 in 1 PACKAGE03/10/202104/12/2021
25200 mL in 1 BOTTLE; Type 0: Not a Combination Product
26NDC: 80948-008-266 in 1 PACKAGE03/10/202104/12/2021
26200 mL in 1 BOTTLE; Type 0: Not a Combination Product
27NDC: 80948-008-2712 in 1 PACKAGE03/10/202104/12/2021
27200 mL in 1 BOTTLE; Type 0: Not a Combination Product
28NDC: 80948-008-2824 in 1 PACKAGE03/10/202104/12/2021
28200 mL in 1 BOTTLE; Type 0: Not a Combination Product
29NDC: 80948-008-294 in 1 PACKAGE03/10/202104/12/2021
29220 mL in 1 BOTTLE; Type 0: Not a Combination Product
30NDC: 80948-008-306 in 1 PACKAGE03/10/202104/12/2021
30220 mL in 1 BOTTLE; Type 0: Not a Combination Product
31NDC: 80948-008-3112 in 1 PACKAGE03/10/202104/12/2021
31220 mL in 1 BOTTLE; Type 0: Not a Combination Product
32NDC: 80948-008-3224 in 1 PACKAGE03/10/202104/12/2021
32220 mL in 1 BOTTLE; Type 0: Not a Combination Product
33NDC: 80948-008-332 in 1 PACKAGE03/10/202104/12/2021
33250 mL in 1 BOTTLE; Type 0: Not a Combination Product
34NDC: 80948-008-344 in 1 PACKAGE03/10/202104/12/2021
34250 mL in 1 BOTTLE; Type 0: Not a Combination Product
35NDC: 80948-008-356 in 1 PACKAGE03/10/202104/12/2021
35250 mL in 1 BOTTLE; Type 0: Not a Combination Product
36NDC: 80948-008-3612 in 1 PACKAGE03/10/202104/12/2021
36250 mL in 1 BOTTLE; Type 0: Not a Combination Product
37NDC: 80948-008-3724 in 1 PACKAGE03/10/202104/12/2021
37250 mL in 1 BOTTLE; Type 0: Not a Combination Product
38NDC: 80948-008-382 in 1 PACKAGE03/10/202104/12/2021
38300 mL in 1 PACKAGE; Type 0: Not a Combination Product
39NDC: 80948-008-394 in 1 PACKAGE03/10/202104/12/2021
39300 mL in 1 PACKAGE; Type 0: Not a Combination Product
40NDC: 80948-008-406 in 1 PACKAGE03/10/202104/12/2021
40300 mL in 1 PACKAGE; Type 0: Not a Combination Product
41NDC: 80948-008-4112 in 1 PACKAGE03/10/202104/12/2021
41300 mL in 1 PACKAGE; Type 0: Not a Combination Product
42NDC: 80948-008-4224 in 1 PACKAGE03/10/202104/12/2021
42300 mL in 1 PACKAGE; Type 0: Not a Combination Product
43NDC: 80948-008-432 in 1 PACKAGE03/10/202104/12/2021
43350 mL in 1 BOTTLE; Type 0: Not a Combination Product
44NDC: 80948-008-444 in 1 PACKAGE03/10/202104/12/2021
44350 mL in 1 BOTTLE; Type 0: Not a Combination Product
45NDC: 80948-008-456 in 1 PACKAGE03/10/202104/12/2021
45350 mL in 1 BOTTLE; Type 0: Not a Combination Product
46NDC: 80948-008-4612 in 1 PACKAGE03/10/202104/12/2021
46350 mL in 1 BOTTLE; Type 0: Not a Combination Product
47NDC: 80948-008-4724 in 1 PACKAGE03/10/202104/12/2021
47350 mL in 1 BOTTLE; Type 0: Not a Combination Product
48NDC: 80948-008-485000 mL in 1 CAN; Type 0: Not a Combination Product03/10/202104/12/2021
49NDC: 80948-008-4950000 mL in 1 CAN; Type 0: Not a Combination Product03/10/202104/12/2021
50NDC: 80948-008-50200000 mL in 1 DRUM; Type 0: Not a Combination Product03/10/202104/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/10/202104/12/2021
Labeler - ZENITH MICRO CONTROL (915625571)
Establishment
NameAddressID/FEIBusiness Operations
ZENITH MICRO CONTROL915625571manufacture(80948-008)

Revised: 4/2021
 

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