ACNE RELIEF CREAM- salicylic acid 0.5% cream

Acne Relief Cream by

Drug Labeling and Warnings

Acne Relief Cream by is a Otc medication manufactured, distributed, or labeled by HEMPFUSION, INC., Universal Packaging Systems, Inc. (DBA Paklab). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic Acid 0.5%

Purpose

Salicylic Acid 0.5%..Acne Treatment

Uses

For the treatment of acne.

Warnings

For external use only

When using this product

• using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
• avoid contact with eyes. If contact occurs, flush thoroughly with water.

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

Directions

• cleanse the skin thoroughly before applying the medication
• cover 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 of peeling occurs, reduce application to once a day or every other day

Other information

• Store in a cool dry place away from light

Inactive ingredients

water (aqua), coco-caprylate, organic dog rose (rosa canina) fruit oil, glycerin, methylsulfonylmethane (MSM), cetearyl alcohol, cetearyl olivate, citric acid, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, zinc oxide (Cl 77947), sorbitan olivate, caprylic/capric triglyceride, willow (salix nigra) bark extract, oat (avena sativa) kernel flour, organic aloe (aloe barbadensis) leaf juice, black pepper (piper nigrum) fruit oil, clove (syzygium aromaticum) flower oil, cetearyl glucoside, glucose, polyhydroxystearic acid, lysolecithin, pullulan, xanthan gum, sclerotium gum, isostearic acid, linalool, limonene, silica, lactoperoxidase, glucose oxidase, organic cypress (cupressus sempervirens) oil, organic lavender (lavandula angustifolia) oil, peppermint (mentha piperita) oil

QUESTIONS

Manufactured for HempFusion(r)

3820 NW 14th Street Suite A & B

Topeka, ks 66618

877.NOW.HEMP (877.669.4367)

hempfusion.com

PRINCIPAL DISPLAY PANEL

HempFusion

Acne

Relief

CREAM

Salicylic Acid 0.5%

Including nourishing Willow Bark, hemp extract with naturally occuring CBD (60mg/bottle) + Terpenes (35mg/bottle) from black pepper and clove & other natural skin moisturizers

US HEMP AUTHORITY H CERTIFIED

NON-GMO

ALL SKIN TYPES

30mL (1.01 fl oz)

INGREDIENTS AND APPEARANCE

ACNE RELIEF CREAM 
salicylic acid 0.5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73672-981
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)
PEPPERMINT OIL (UNII: AV092KU4JH)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
SORBITAN OLIVATE (UNII: MDL271E3GR)
OATMEAL (UNII: 8PI54V663Y)
ALOE (UNII: V5VD430YW9)
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)
MYELOPEROXIDASE (UNII: JQZ6YM58U5)
COCO-CAPRYLATE (UNII: 4828G836N6)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HEMP (UNII: TD1MUT01Q7)
ZINC OXIDE (UNII: SOI2LOH54Z)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
XANTHAN GUM (UNII: TTV12P4NEE)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
WILLOW BARK (UNII: S883J9JDYX)
BLACK PEPPER OIL (UNII: U17J84S19Z)
CLOVE OIL (UNII: 578389D6D0)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PULLULAN (UNII: 8ZQ0AYU1TT)
ISOSTEARIC ACID (UNII: X33R8U0062)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
LAVENDER OIL (UNII: ZBP1YXW0H8)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73672-981-30	1 in 1 CARTON	02/10/2020
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/10/2020

Labeler - Metacan Inc Ste (034175227)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		078717086	manufacture(73672-981)