SAFETY FIRST- alcohol liquid

Safety First by

Drug Labeling and Warnings

Safety First by is a Otc medication manufactured, distributed, or labeled by Clean Beauty Concepts. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

The sanitizer wipes is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

1. Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (75%, 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
3. Hydrogen peroxide
4. Sterile distilled water or boiled cold water. (27.465%)
5. Fragrance (Parfum)
6. Aloe vera leaf extract
7. Tocopheryl Acetate (Vitamin E)
8. Aminomethyl Propanol

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antibacterial

Use

Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.

Warnings

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

Do not use

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

WHEN USING

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

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

Keep out of reach of 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 age 6 when using this product to avoid swallowing

Other information

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

Inactive ingredients

water(aqua), glycerin, aloe vera barbadensis (aloe vera) leaf extract, tocopheryl acetate (Vitamine E), hydrogen peroxide, Aminomethyl Propanol, fragrance(parfum)

Package Label - Principal Display Panel

3875 mL NDC: 76665-011-01

473 mL NDC: 76665-011-16

236mL NDC: 76665-011-08

INGREDIENTS AND APPEARANCE

SAFETY FIRST 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76665-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS SMITHII OIL (UNII: X4023CB3OK)	0.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)	0.2 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.1 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.06 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	27.665 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)	0.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76665-011-01	3875 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/17/2020
2	NDC: 76665-011-16	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/17/2020
3	NDC: 76665-011-08	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/17/2020

Labeler - Clean Beauty Concepts (117491649)

Establishment
Name	Address	ID/FEI	Business Operations
Clean Beauty Concepts		117491649	manufacture(76665-011)