REAL TIME HAND SANITIZER 70% ALCOHOL- alcohol hand sanitizer gel

Real Time Hand Sanitizer 70% Alcohol by

Drug Labeling and Warnings

Real Time Hand Sanitizer 70% Alcohol by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Alcohol 70% v/v

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.

Flammable - Keep away from fire or flame.

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

Use 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 this product.

Other information

• Do not store above 110°F (43°C)
• May discolor fabrics or surfaces

Inactive Ingredients

Aloe Barbadensis Leaf Juice,
Butylene Glycol, C13-14 Isoparaffin, Caprylyl Glycol,
Chamomilla recutita (Matricaria) Flower Extract,
Glycerin, Laureth-7, Phenoxyethanol,
Polyacrylamide, Purified Water, Tocopheryl Acetate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REAL TIME HAND SANITIZER 70% ALCOHOL 
alcohol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-957
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
LAURETH-7 (UNII: Z95S6G8201)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-957-15	44 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
2	NDC: 58133-957-03	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
3	NDC: 58133-957-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
4	NDC: 58133-957-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
5	NDC: 58133-957-40	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
6	NDC: 58133-957-16	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
7	NDC: 58133-957-28	3789 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/03/2020

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Registrant - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs, Inc.		032973000	manufacture(58133-957)