HAND SANITIZER- hand sanitizer gel 
TRININE WELLNESS LLC

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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004 Hand sanitizer

Active Ingredient(s)

Ethyl Alcohol 75%

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce germs on skin that could cause disease.

Recommended for repeated use.

Warnings

For external use only: hands.Flammable. Keep away from heat, fire, or flame.

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, rash, or redness develops and lasts.

Keep out of reach for children. If swallowed, get medical help or contact a

Poison Control Center right away.

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, rash, or redness develops and lasts.

Keep out of reach for 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.

Other information

Store below 106ºF. (41 ºC).

May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Carbomer (Gel), Melaleuca Oil (Tea Tree Oil), Aloe Barbadensis Leaf Extract

(Aloe), Tocopherols (Vitamin E), Mentha × piperita (Peppermint), CI 61570 (Cosmetic Coloring), Triethaolamine (Tea)

Label

79054-004-07 3785ml79054-004-02 60ml79054-004-03 120ml79054-004-01 50ml79054-004-05 500ml79054-004-06 1000ml79054-004-04 236ml

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79054-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TEA TREE OIL (UNII: VIF565UC2G)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
PEPPERMINT (UNII: V95R5KMY2B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79054-004-073785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
2NDC:79054-004-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
3NDC:79054-004-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
4NDC:79054-004-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/12/2020
5NDC:79054-004-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/12/2020
6NDC:79054-004-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
7NDC:79054-004-03120 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/10/2020
Labeler - TRININE WELLNESS LLC (117522591)
Establishment
NameAddressID/FEIBusiness Operations
TRININE WELLNESS LLC117522591manufacture(79054-004)

Revised: 8/2020
Document Id: ad21b0cf-2997-cb3c-e053-2a95a90a3724
Set id: ad21b0cf-2998-cb3c-e053-2a95a90a3724
Version: 1
Effective Time: 20200818
 
TRININE WELLNESS LLC