FDA.reportPublic FDA data

Olika Hydrating Hand Sanitizer Cotton Flower

Manufacturer
Olika Inc.
Effective date
2021-12-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:45:37

Key Label Information#

Active Ingredients And Purpose

Active Ingredient(s)

Ethyl Alcohol 65% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Uses

Use

Helps reduce bacteria on skin.

Warnings

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

Directions And Dosage

Directions

Spray liquid into hands and rub until dry. Use as often as needed.

Other Label Information

Other information

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

aloe vera, fragrance, glycerin, hyaluronic acid, reishi mushrooms, water

Package Label - Principal Display Panel and Information Panels

90 mL NDC: 76751-711-01

Package Label - Principal Display Panel and Information Panels

76751-711-02. 20 mL

Label Images#

BOTTLE_PRINTING_SAMPLE
BOTTLE_PRINTING_SAMPLE
MINDFULNESS_FINAL_90ML_COTTONFLOWER_052221
MINDFULNESS_FINAL_90ML_COTTONFLOWER_052221
MINDFULNESS_FINAL_20ML_COTTONFLOWER_052221
MINDFULNESS_FINAL_20ML_COTTONFLOWER_052221
MINDFULNESS_FINAL_90ML_BLUETANSY_052221
MINDFULNESS_FINAL_90ML_BLUETANSY_052221
MINDFULNESS_FINAL_20ML_BLUETANSY_052221
MINDFULNESS_FINAL_20ML_BLUETANSY_052221
MINDFULNESS_FINAL_90ML_EUCALYPTUS_052221
MINDFULNESS_FINAL_90ML_EUCALYPTUS_052221
MINDFULNESS_FINAL_20ML_EUCALYPTUS_052221
MINDFULNESS_FINAL_20ML_EUCALYPTUS_052221

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902515ethanol 65 % Topical SprayPSN3
902515ethanol 0.65 ML/ML Topical SpraySCD3
902515ethanol 65 % Topical SpraySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76751-711-012023-01-30C16284748780-1f386c649-f4b9-0266-e053-dadaa90a7c1aOlika Mindfulness Hand Sanitizers- 3 scents in 20 mL, 90 mL
76751-711-022023-01-30C16284748780-1f386c649-f4b9-0266-e053-dadaa90a7c1aOlika Mindfulness Hand Sanitizers- 3 scents in 20 mL, 90 mL
76751-712-012023-01-30C16284748780-1f386c649-f4b9-0266-e053-dadaa90a7c1aOlika Mindfulness Hand Sanitizers- 3 scents in 20 mL, 90 mL
76751-712-022023-01-30C16284748780-1f386c649-f4b9-0266-e053-dadaa90a7c1aOlika Mindfulness Hand Sanitizers- 3 scents in 20 mL, 90 mL
76751-713-012023-01-30C16284748780-1f386c649-f4b9-0266-e053-dadaa90a7c1aOlika Mindfulness Hand Sanitizers- 3 scents in 20 mL, 90 mL
76751-713-022023-01-30C16284748780-1f386c649-f4b9-0266-e053-dadaa90a7c1aOlika Mindfulness Hand Sanitizers- 3 scents in 20 mL, 90 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76751-711-01Olika Hydrating Hand Sanitizer Cotton Flower90 mL in 1 POUCHLIQUID903
76751-711-02Olika Hydrating Hand Sanitizer Cotton Flower1 in 1 BLISTER PACKLIQUID13
76751-711-20Olika Hydrating Hand Sanitizer Cotton Flower20 mL in 1 BOTTLE, SPRAYLIQUID203
76751-712-01Olika Hydrating Hand Sanitizer Blue Tansy90 mL in 1 POUCHLIQUID903
76751-712-02Olika Hydrating Hand Sanitizer Blue Tansy1 in 1 BLISTER PACKLIQUID13
76751-712-20Olika Hydrating Hand Sanitizer Blue Tansy20 mL in 1 BOTTLE, SPRAYLIQUID203
76751-713-00Olika Hydrating Hand Sanitizer Frosted Eucalyptus20 mL in 1 BOTTLE, SPRAYLIQUID203
76751-713-01Olika Hydrating Hand Sanitizer Frosted Eucalyptus90 mL in 1 POUCHLIQUID903
76751-713-02Olika Hydrating Hand Sanitizer Frosted Eucalyptus1 in 1 BLISTER PACKLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76751-711OLIKA HYDRATING HAND SANITIZER FROSTED EUCALYPTUS (ALCOHOL) LIQUID OLIKA HYDRATING HAND SANITIZER BLUE TANSY (ALCOHOL) LIQUID OLIKA HYDRATING HAND SANITIZER COTTON FLOWER (ALCOHOL) LIQUID [OLIKA INC.]3Legacy NDC, 3 package rows20211214_c19dabfe-de01-2c4d-e053-2a95a90a8dad.zip
76751-712OLIKA HYDRATING HAND SANITIZER FROSTED EUCALYPTUS (ALCOHOL) LIQUID OLIKA HYDRATING HAND SANITIZER BLUE TANSY (ALCOHOL) LIQUID OLIKA HYDRATING HAND SANITIZER COTTON FLOWER (ALCOHOL) LIQUID [OLIKA INC.]3Legacy NDC, 3 package rows20211214_c19dabfe-de01-2c4d-e053-2a95a90a8dad.zip
76751-713OLIKA HYDRATING HAND SANITIZER FROSTED EUCALYPTUS (ALCOHOL) LIQUID OLIKA HYDRATING HAND SANITIZER BLUE TANSY (ALCOHOL) LIQUID OLIKA HYDRATING HAND SANITIZER COTTON FLOWER (ALCOHOL) LIQUID [OLIKA INC.]3Legacy NDC, 3 package rows20211214_c19dabfe-de01-2c4d-e053-2a95a90a8dad.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76751-71376751-713-00, 76751-713-02, 76751-713-01
76751-71276751-712-20, 76751-712-02, 76751-712-01
76751-71176751-711-20, 76751-711-02, 76751-711-01

Ingredients#

Name, UNII, Kind table
NameUNIIKind
ACETYL CEDRENEX6I62755AKIACT
IONONEQP734LIN1KIACT
ETHYL LINALOOLSF2JS9GF5TIACT
ETHYL BUTYRATEUFD2LZ005DIACT
FLORALOZONE1HA71K8K9LIACT
METHYL BENZODIOXEPINONE0NQ136C313IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
NERYL ACETATEOF82IJU18HIACT
DIPROPYLENE GLYCOLE107L85C40IACT
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OLVK5ZHH2T3FIACT
ALLYL HEPTANOATEAU4CYG9V68IACT
METHYL DIHYDROJASMONATE (SYNTHETIC)3GW44CIE3YIACT
DIHYDROMYRCENOL46L1B02ND9IACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
3-ISOCAMPHYLCYCLOHEXANOL, TRANS-34UP96K73ZIACT
HEXYL ACETATE7U7KU3MWT0IACT
GERANYL ACETATE3W81YG7P9RIACT
ETHYL ACETOACETATE ETHYLENEGLYCOL KETALG5EXI4NID0IACT
PENTADECALACTONEOK17S3S98KIACT
CYCLOPENTANONE220W81TN3SIACT
ETHYL 2,4-DECADIENOATE, (2E,4Z)-79P6KS9Y5ZIACT
4-(P-HYDROXYPHENYL)-2-BUTANONE7QY1MH15BGIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ALLYL .ALPHA.-IONONE8IP66F9ODGIACT
ALLYL HEXANOATE3VH84A363DIACT
ALLYL CYCLOHEXANEACETATEM6J8835739IACT
3-HEXEN-1-OL, (3Z)-V14F8G75P4IACT
ALOE VERA LEAFZY81Z83H0XIACT
REISHITKD8LH0X2ZIACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES2JU6ZH6GREIACT
DIPROPYLENE GLYCOLE107L85C40IACT
ETHYL 2-METHYLBUTYRATEL1T4AB29DSIACT
METHYL DIHYDROJASMONATE (SYNTHETIC)3GW44CIE3YIACT
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OLVK5ZHH2T3FIACT
CYCLODODECANE97CN13ZD83IACT
2-TERT-BUTYLCYCLOHEXYL ACETATE364FV60913IACT
NAPHTHO(2,1-B)FURAN5O098D6W4TIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
4-HYDROXY-1-(5-ISOCAMPHYL)CYCLOHEXANETVJ25725XPIACT
DIETHYL MALONATE53A58PA183IACT
2,4-DIMETHYL-4-NONANOL625246Q74QIACT
4-TERT-BUTYLCYCLOHEXYL ACETATE21EUM2B8UCIACT
3-ISOCAMPHYLCYCLOHEXANOL, TRANS-34UP96K73ZIACT
CEDRYL ACETATE0WS0WJ9WNVIACT
AMBROXIDE, (-)-TD34B3O8M9IACT
METHYL 3-METHYLORSELLINATE12YH9T04QEIACT
4-METHYL-3-DECEN-5-OL, (3E)-5S5I61TY7PIACT
DIHYDRODEHYDRO-.BETA.-IONONEXZS4VD987OIACT
ETHYL 2-METHYLPENTANOATE405SN8638DIACT
.GAMMA.-DECALACTONE7HLS05KP9OIACT
DECAHYDRO-2,2,6,6,7,8,8-HEPTAMETHYL-2H-INDENO(4,5-B)FURAN89ZYZ7YI66IACT
METHYL ANTHRANILATE981I0C1E5WIACT
2,4-DIMETHYL-3-CYCLOHEXENE CARBOXALDEHYDE452GFV2AFSIACT
3-HEXEN-1-OL, (3Z)-V14F8G75P4IACT
HEX-3-EN-1-YL METHYL CARBONATE, (3Z)-WEC5YY1PGTIACT
DIMETHYLCYCLOHEXYLETHOXY ISOBUTYLPROPANOATEI1AI9W9CABIACT
ETHYL MALTOLL6Q8K29L05IACT
ALLYL CYCLOHEXANEACETATEM6J8835739IACT
1-METHYL-2-(((1R,3S,5S)-1,2,2-TRIMETHYLBICYCLO HEX-3-YL)METHYL)CYCLOPROPANEMETHANOL, (1R,2R)-56FP2ES9B7IACT
REISHITKD8LH0X2ZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
METHYL DIHYDROJASMONATE (SYNTHETIC)3GW44CIE3YIACT
2,2,5-TRIMETHYLHEXANEAGW1Z6985EIACT
DIHYDRODEHYDRO-.BETA.-IONONEXZS4VD987OIACT
2,4-DIMETHYL-3-CYCLOHEXENE CARBOXALDEHYDE452GFV2AFSIACT
.GAMMA.-DECALACTONE7HLS05KP9OIACT
.ALPHA.-METHYLBENZYL ACETATEFYS3E9NBA3IACT
ETHYL 2,2-DIMETHYLHYDROCINNAMAL5V2FN5AA3WIACT
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OLVK5ZHH2T3FIACT
4-HYDROXY-1-(5-ISOCAMPHYL)CYCLOHEXANETVJ25725XPIACT
.GAMMA.-UNDECALACTONEQB1T0AG2YLIACT
NAPHTHO(2,1-B)FURAN5O098D6W4TIACT
3-HEXENYL ACETATE, (3Z)-6INA6GC5I6IACT
DIPROPYLENE GLYCOLE107L85C40IACT

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the1994 tentative final monograph for hand sanitizers and antiseptics. Final formulation finished product testing was performed to confirm efficacy and quality assurance. The formulation comes in 2 package sizes: 20 mL and 90mL

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Helps reduce bacteria on skin.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

in children less than 2 months of age on open skin wounds

OTC - WHEN USING SECTION

OTC - WHEN USING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Spray liquid into hands and rub until dry. Use as often as needed.

Other information

STORAGE AND HANDLING SECTION

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, fragrance, glycerin, hyaluronic acid, reishi mushrooms, water

20 mL Primary Container Spray Bottle Bottom Label

SPL UNCLASSIFIED SECTION

76751-711-02; 76751-712-02; 76751-713-02 20 mL Primary Container Spray Bottle Bottom Label

Package Label - Principal Display Panel and Information Panels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

90 mL NDC: 76751-711-01

Package Label - Principal Display Panel and Information Panels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

76751-711-02. 20 mL

Package Label - Principal Display Panel and Information Panels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

76751-712-01 90 mL

Package Label - Principal Display Panel and Information Panels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

76751-712-02. 20 mL

Package Label - Principal Display Panel and Information Panels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

76751-713-01. 90mL

Package Label - Principal Display Panel and Information Panels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

76751-713-02 20 mL

Source Document#

Source XML