BIOARMOUR HAND SANITIZER SQUEEZE HOSE- alcohol gel
Ningbo Pretty Tourism Manufacturer Co. Ltd.

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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BioArmour Hand Sanitizer (PE bottle (screw cap) large)

Active Ingredient(s)

Ethyl Alcohol 70% Purpose: Antimicrobial

Purpose

Antimicrobial

Uses

Use(s)

For handwashing to decrease bacteria on the skin
Recommended for repeated use

Warnings

For external use only. Flammable, keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

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

Directions

Wet hands thoroughly with product
Briskly rub hands together until dry
Supervise children under 6 years in the use of this product

Other information

Store at 20 oC to 25 oC (68 o to 77 oF)
May discolor certain fabrics

Inactive ingredients

Water (aqua), Triethanolamine, Carbomer, Propylene Glycol, Glycerin, Aloe Barbadensis Extract, Tocopheryl Acetate

Label

BIOARMOUR HAND SANITIZER SQUEEZE HOSE
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75749-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 L in 100 L

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75749-004-01	1 L in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2020
2	NDC:75749-004-02	2 L in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2020
3	NDC:75749-004-03	2.5 L in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2020
4	NDC:75749-004-08	15 L in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2020
5	NDC:75749-004-04	5 L in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2020
6	NDC:75749-004-06	10 L in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2020
7	NDC:75749-004-07	12.5 L in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2020
8	NDC:75749-004-05	6 L in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2020
9	NDC:75749-004-09	20 L in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2020
10	NDC:75749-004-10	25 L in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2020
11	NDC:75749-004-11	28 L in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2020
12	NDC:75749-004-12	30 L in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/28/2020

Labeler - Ningbo Pretty Tourism Manufacturer Co. Ltd. (553193489)

Name	Address	ID/FEI	Business Operations
Establishment
Ningbo Pretty Tourism Manufacturer Co. Ltd.		553193489	manufacture(75749-004)