OLIKA HAND SANITIZER ORANGE BLOSSOM- ethyl alcohol liquid 
OLIKA HAND SANITIZER LAVENDER- ethyl alcohol liquid 
OLIKA HAND SANITIZER CHARCOAL- ethyl alcohol liquid 
OLIKA HAND SANITIZER CUCUMBER BASIL- ethyl alcohol liquid 
OLIKA HAND SANITIZER MINT CITRUS- ethyl alcohol liquid 
Olika Inc.

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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OLIKA Hand Sanitizers in 5 scents in 3 sizes each 20 mL, 30 mL, 90 mL

These products are hand sanitizers manufactured according to the 1994 tentative final monograph for antiseptics with additional guidance taken from subsequent rule makings and guidances.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation).

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (65%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (4.2% v/v).
  3. Aloe Barbadensis Leaf Extract.
  4. Sterile distilled water or boiled cold water.
  5. Fragrance

The finished product formulation underwent third party efficacy testing (kill study) to confirm efficacy and product potency.

The hand sanitizer come in 6 different scents. Fragrance free (submitted separately NDC 76751-211), Lavender (NDC 76751-611), Orange Blossom (NDC 76751-511), Mint Citrus (NDC 76751-111), Charcoal (NDC 76751-311) and Cucumber Basil (NDC 76751-411).

Active Ingredient(s)

Alcohol 65% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Warnings

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

Do not use

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.

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.

Other information

Use

Helps reduce bacteria on skin.

Directions

Inactive Ingredients

Inactive Ingredients for NDCs 76751-111-01; 76751-311-01; 76751-411-01; 76751-511-01; 76751-611-01

Primary container spray bottle bottom label

Bottom label for primary container spray bottle for all scents:

Bottle printed label on bottom

76751-411-01 Prinicipal Display Panel and information panel image

76751-411-01 30 mL

76751-411-01

76751-111-01 Prinicipal Display Panel and information Panel

30 mL NDC 76751-111-01

111-01

76751-311-01 Image Principal Display Panel & Information Panel

30 mL NDC 76751-311-01

76751-311-01

76751-511-01 Principal Display panel and information panel

30mL NDC 76751-511-01

511-01

76751-111-02 Principal Display and Information Panel

20 mL NDC 76751-111-02

111-02

76751-311-02 Principal Display and Information Panel

20mL NDC 76751-311-02

311-02

76751-611-02 PRINCIPAL DISPLAY PANEL AND INFORMATION LABEL

20 mL NDC 76751-611-02

611-02

76751-411-02 PRINCIPAL DISPLAY PANEL AND INFORMATION PANEL

20 mL NDC 76751-411-02

411-02

76751-111-03 PRINCIPAL DISCPLAY PANEL AND INFORMATION PANEL

90 mL NDC 76751-111-03

111-03

76751-611-03 PRINCIPAL DISPLAY PANEL AND INFORMATION PANEL

90 mL NDC 76751-611-03

611-30 90mL

76751-311-03 PRINCIPAL DISPLAY PANEL AND INFORMATION PANEL

90 mL NDC 76751-311-03

311-03

76751-411-03 PRINCIPAL DISPLAY PANEL AND INFORMATION PANEL

90 mL NDC 76751-411-03

411-03

76751-511-03 PRINCIPAL DISPLAY PANEL AND INFORMATON PANEL

90 mL NDC 76751-511-03

511-03

76751-611-01 PRINCIPAL DISPLAY PANEL AND INFORMATION PANEL

30mL NDC 76751-611-01

611-01

76751-511-02 PRINCIPAL DISPLAY PANEL AND INFORMATION PANEL

20 mL NDC 76751-511-02

511-02

OLIKA HAND SANITIZER ORANGE BLOSSOM 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76751-511
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PIPERONAL (UNII: KE109YAK00) 0.0003 mL  in 100 mL
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) 0.0007 mL  in 100 mL
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) 0.0005 mL  in 100 mL
TRIETHYL CITRATE (UNII: 8Z96QXD6UM) 0.3368 mL  in 100 mL
LINALOOL, (-)- (UNII: 3U21E3V8I2) 0.017 mL  in 100 mL
.ALPHA.-TERPINEOL (UNII: 21334LVV8W) 0.0048 mL  in 100 mL
PALMAROSA OIL (UNII: 0J3G3O53ST) 0.0096 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 4.2 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 30.05 mL  in 100 mL
MALTOL (UNII: 3A9RD92BS4) 0.0003 mL  in 100 mL
.DELTA.-DODECALACTONE (UNII: 33DIC582TL) 0.0002 mL  in 100 mL
BENZYL SALICYLATE (UNII: WAO5MNK9TU) 0.0013 mL  in 100 mL
LITSEA OIL (UNII: 2XIW34BN6O) 0.0032 mL  in 100 mL
ORANGE OIL (UNII: AKN3KSD11B) 0.0028 mL  in 100 mL
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9) 0.0002 mL  in 100 mL
.DELTA.-DECALACTONE (UNII: CNA0S5T234) 0.0013 mL  in 100 mL
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) 0.0006 mL  in 100 mL
VANILLIN (UNII: CHI530446X) 0.0005 mL  in 100 mL
CARDAMOM OIL (UNII: JM0KJ091HZ) 0.0002 mL  in 100 mL
METHYL ANTHRANILATE (UNII: 981I0C1E5W) 0.001 mL  in 100 mL
CITRUS SINENSIS LEAF (UNII: VF01D90MZI) 0.0084 mL  in 100 mL
CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M) 0.0029 mL  in 100 mL
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K) 0.0005 mL  in 100 mL
BERGAMOT OIL (UNII: 39W1PKE3JI) 0.0112 mL  in 100 mL
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO) 0.0006 mL  in 100 mL
.GAMMA.-DECALACTONE (UNII: 7HLS05KP9O) 0.0006 mL  in 100 mL
MANDARIN OIL (UNII: NJO720F72R) 0.0016 mL  in 100 mL
CLOVE LEAF OIL (UNII: VCA5491KVF) 0.0026 mL  in 100 mL
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP) 0.0888 mL  in 100 mL
ALLYL HEXANOATE (UNII: 3VH84A363D) 0.0013 mL  in 100 mL
LEMON OIL (UNII: I9GRO824LL) 0.0002 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76751-511-0390 mL in 1 POUCH; Type 0: Not a Combination Product06/01/2020
2NDC:76751-511-0130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
3NDC:76751-511-0220 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
OLIKA HAND SANITIZER LAVENDER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76751-611
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SPEARMINT OIL (UNII: C3M81465G5) 0.005991 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 4.2 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 30.05 mL  in 100 mL
DIPTERYX ODORATA SEED (UNII: D43A5L1U6L) 0.013825 mL  in 100 mL
VANILLIN (UNII: CHI530446X) 0.0013825 mL  in 100 mL
TRIETHYL CITRATE (UNII: 8Z96QXD6UM) 0.3364055 mL  in 100 mL
LAVANDIN OIL (UNII: 9RES347CKG) 0.0557605 mL  in 100 mL
LEMON OIL (UNII: I9GRO824LL) 0.0073735 mL  in 100 mL
LINALOOL, (-)- (UNII: 3U21E3V8I2) 0.00599 mL  in 100 mL
AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E) 0.002765 mL  in 100 mL
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO) 0.010599 mL  in 100 mL
BULNESIA SARMIENTOI WOOD OIL (UNII: 81H0L6W02F) 0.032258 mL  in 100 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) 0.0152075 mL  in 100 mL
JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686) 0.0124425 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76751-611-0390 mL in 1 POUCH; Type 0: Not a Combination Product06/01/2020
2NDC:76751-611-0130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
3NDC:76751-611-0220 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
OLIKA HAND SANITIZER CHARCOAL 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76751-311
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65.1846 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIN RESIN (UNII: GK21SBA74R) 0.0013 mL  in 100 mL
LINALYL ACETATE (UNII: 5K47SSQ51G) 0.0074 mL  in 100 mL
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G) 0.0176 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 4.2 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 30.05 mL  in 100 mL
LINALOOL, (-)- (UNII: 3U21E3V8I2) 0.0098 mL  in 100 mL
VANILLIN (UNII: CHI530446X) 0.0028 mL  in 100 mL
LEMON OIL (UNII: I9GRO824LL) 0.0113 mL  in 100 mL
CLARY SAGE OIL (UNII: 87L0D4U3M0) 0.0007 mL  in 100 mL
BERGAMOT OIL (UNII: 39W1PKE3JI) 0.0078 mL  in 100 mL
VETIVER OIL (UNII: 9M9P32M01L) 0.0002 mL  in 100 mL
TRIETHYL CITRATE (UNII: 8Z96QXD6UM) 0.242 mL  in 100 mL
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO) 0.0061 mL  in 100 mL
AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E) 0.003 mL  in 100 mL
BENZYL ACETATE (UNII: 0ECG3V79ZJ) 0.0026 mL  in 100 mL
LABDANUM OIL (UNII: 67GS9BGA2X) 0.0019 mL  in 100 mL
.BETA.-IONONE (UNII: A7NRR1HLH6) 0.0009 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76751-311-0390 mL in 1 POUCH; Type 0: Not a Combination Product06/01/2020
2NDC:76751-311-0130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
3NDC:76751-311-0220 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
OLIKA HAND SANITIZER CUCUMBER BASIL 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76751-411
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65.2459 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CUCUMBER JUICE (UNII: 61845009SP) 0.0074 mL  in 100 mL
SWEET VIOLET LEAF OIL (UNII: 227KB7O2KN) 0.0002 mL  in 100 mL
BASIL OIL (UNII: Z129UMU8LE) 0.0007 mL  in 100 mL
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G) 0.0032 mL  in 100 mL
MIMOSA TENUIFLORA BARK (UNII: 515MQE449I) 0.0001 mL  in 100 mL
3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4) 0.0012 mL  in 100 mL
EUGENOL (UNII: 3T8H1794QW) 0.0007 mL  in 100 mL
.GAMMA.-DECALACTONE (UNII: 7HLS05KP9O) 0.0007 mL  in 100 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.0176 mL  in 100 mL
LINALOOL, (-)- (UNII: 3U21E3V8I2) 0.0147 mL  in 100 mL
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP) 0.0206 mL  in 100 mL
HEXYL ACETATE (UNII: 7U7KU3MWT0) 0.0018 mL  in 100 mL
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9) 0.0012 mL  in 100 mL
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) 0.0009 mL  in 100 mL
TRIETHYL CITRATE (UNII: 8Z96QXD6UM) 0.1779 mL  in 100 mL
LITSEA OIL (UNII: 2XIW34BN6O) 0.0029 mL  in 100 mL
ORANGE OIL (UNII: AKN3KSD11B) 0.0001 mL  in 100 mL
NEROLIDOL (UNII: QR6IP857S6) 0.0006 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 4.2 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 30.05 mL  in 100 mL
ANETHOLE (UNII: Q3JEK5DO4K) 0.0015 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76751-411-0390 mL in 1 POUCH; Type 0: Not a Combination Product06/01/2020
2NDC:76751-411-0130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
3NDC:76751-411-0220 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
OLIKA HAND SANITIZER MINT CITRUS 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76751-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LEMON OIL (UNII: I9GRO824LL) 0.01923 mL  in 100 mL
CARAWAY OIL (UNII: C2J9B08Q3I) 0.0769 mL  in 100 mL
GRAPEFRUIT OIL (UNII: YR377U58W9) 0.0077 mL  in 100 mL
TRIETHYL CITRATE (UNII: 8Z96QXD6UM) 0.5577 mL  in 100 mL
BERGAMOT OIL (UNII: 39W1PKE3JI) 0.1462 mL  in 100 mL
SPEARMINT OIL (UNII: C3M81465G5) 0.0192 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 4.2 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 29.55 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76751-111-0390 mL in 1 POUCH; Type 0: Not a Combination Product06/01/2020
2NDC:76751-111-0130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
3NDC:76751-111-0220 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - Olika Inc. (080476192)

Revised: 12/2021
Document Id: d2d8a0be-565e-4b9a-e053-2a95a90a495e
Set id: a40f4421-88f2-0fe2-e053-2995a90a69b7
Version: 5
Effective Time: 20211210
 
Olika Inc.