Apollo Instant Hand Sanitizer (new Formulation)

Apollo Instant Hand Sanitizer (new Formulation)
SPL v3
SPL
SPL Set ID a91a1b64-2993-4628-e053-2a95a90a86e6
Route
TOPICAL
Published
Effective Date 2020-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Linalool, (+/-)- 3-hexenyl Acetate, (3z)- 3-hexen-1-ol, (3z)- Citric Acid Monohydrate Nerol Aminomethylpropanol Aloe Vera Leaf Tocopherol Glycerin Hydroxycitronellal Cyclamen Aldehyde Lactic Acid Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Isopropyl Myristate Edetate Disodium Anhydrous Methyl Dihydrojasmonate (synthetic) Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-02

Description

Alcohol 75%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 75%

Pdp

3785ml NDC: 74658-009-01

Uses:

Hand sanitizer to help decrease bacterial on the skin, when water, soap& towel are not available. Recommended for repeated use.

Section 50565-1

Keep out of reach of children.

Children must be supervised in use of this product.

Section 50566-9

Stop use and ask a doctor

If redness or irritation develop and persist for more than 72 hours

Section 50567-7

When using this product,

Avoid contact with eyes. In case of contact flush eyes with water.

Warnings

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

Do not apply around eyes. Do not use in ears & mouth.

Directions

Place enough product into your palms and thoroughly spread on both hands. Rub into skin until dry.

Active Ingredient

Alcohol 75%

Other Information

Store below 110℉(43℃)

May discolor certain fabrics or surfaces.

Inactive Ingredients

Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Aminomethyl Propanol, Propylene Glycol, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice Power, Lactic Acid, Citric Acid.


Structured Label Content

Pdp (PDP)

3785ml NDC: 74658-009-01

Uses:

Hand sanitizer to help decrease bacterial on the skin, when water, soap& towel are not available. Recommended for repeated use.

Section 50565-1 (50565-1)

Keep out of reach of children.

Children must be supervised in use of this product.

Section 50566-9 (50566-9)

Stop use and ask a doctor

If redness or irritation develop and persist for more than 72 hours

Section 50567-7 (50567-7)

When using this product,

Avoid contact with eyes. In case of contact flush eyes with water.

Purpose

Antiseptic

Warnings

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

Do not apply around eyes. Do not use in ears & mouth.

Directions

Place enough product into your palms and thoroughly spread on both hands. Rub into skin until dry.

Active Ingredient (Active ingredient)

Alcohol 75%

Other Information (Other information)

Store below 110℉(43℃)

May discolor certain fabrics or surfaces.

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Aminomethyl Propanol, Propylene Glycol, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice Power, Lactic Acid, Citric Acid.


Advanced Ingredient Data


Raw Label Data

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