GUARD- alcohol gel
Apollo Health and Beauty Care

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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Guard 8 OZ Hand Sanitizer, SAM- 48776

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

For personal hand hygine to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Warnings

For external use only.

Flammable
Keep away from source of heat or fire.

Do not use

On infants less than 2 months of age.
On open skin wounds
On broken or damaged skin.

When using this product avoid

contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Do not inhale.

Stop use and ask a doctor

if irritation or redness develops and lasts.

Keep out of reach of children

In case of accidental ingestion, get medical help or contact Poison Control Center immediately.

Directions

For occassional and Personal use.
Rub thoroughly into hands for at least 30 seconds. Allo to dry.
Children under 6 years should be supervised when using this product.

Inactive Ingredients

Water (Aqua), PEG-6, AMP-Acrylates/vinyl Isodecanoate Crosspolymer, Fragrance (Parfum), Glycerin, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate.

Package Label

GUARD
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63148-502
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63148-502-08	227 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/01/2023

Labeler - Apollo Health and Beauty Care (201901209)

Registrant - Apollo Health and Beauty Care (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care		201901209	manufacture(63148-502)