HYR FACIAL AND BODY ACNE- salicylic acid spray

HYR Facial and Body Acne by

Drug Labeling and Warnings

HYR Facial and Body Acne by is a Otc medication manufactured, distributed, or labeled by General Resources LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredient

Salicylic Acid, 2%

PURPOSE

Purpose

Acne Treatment

INDICATIONS & USAGE

Uses

for the treatment of acne

WARNINGS

Warnings

For external use only.

Flammable, keep away from fire or flame.

Sunburn Alert:This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun. Avoid unnecessary sun exposure and use a sunscreen of SPF 15 or higher.

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

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

DOSAGE & ADMINISTRATION

Directions

• clean the skin thoroughly before applying this product
• spray the entire affected area with a thin layer one to three times daily
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT

Inactive ingredientswater, glycolic acid, ethyl alcohol, ammonium hydroxide, hamamelis virginiana (witch hazel) water, acetone, polysorbate 20, sodium benzoate, imidazolidinyl urea, disodium EDTA, benzoic acid

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Distributed by: General Resources 227 S Smith Rd Suite 102 Tempe, AZ 85281 www.gen-resources.com

PRINCIPAL DISPLAY PANEL

HYR

FACIAL & BODY

ACNE SPRAY

Salicylic Acid Acne Treatment

Net 2 fl. oz. (60 ml)

Proudly made in the USA

INGREDIENTS AND APPEARANCE

HYR FACIAL AND BODY ACNE 
salicylic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70481-331
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
WITCH HAZEL (UNII: 101I4J0U34)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
AMMONIA (UNII: 5138Q19F1X)
ACETONE (UNII: 1364PS73AF)
GLYCOLIC ACID (UNII: 0WT12SX38S)
IMIDUREA (UNII: M629807ATL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70481-331-06	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/19/2020
2	NDC: 70481-331-12	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/19/2020

Labeler - General Resources LLC (117648210)