Acne Relief Cream: Package Insert and Label Information

ACNE RELIEF CREAM- salicylic acid cream
HEMPFUSION, INC.

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.

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

Manufactured for Hemp Fusion(r)

3820 NW 14th Street Suite A & B

Topeka, ks 66618

877.NOW.HEMP (877.669.4367)

hempfusion.com

Hemp Fusion

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)

Box
(click image for full-size original)
Label
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BLACK PEPPER OIL
CLOVE OIL
CETEARYL GLUCOSIDE
PULLULAN
ISOSTEARIC ACID
LINALOOL, (+/-)-
LIMONENE, (+)-
SILICON DIOXIDE
GLUCOSE OXIDASE
LAVENDER OIL
GLYCERIN
CETEARYL OLIVATE
ROSA CANINA FRUIT OIL
CETOSTEARYL ALCOHOL
ANHYDROUS DEXTROSE
CUPRESSUS SEMPERVIRENS LEAF OIL
PEPPERMINT OIL (PEPPERMINT)
CANNABIS SATIVA SEED OIL
SORBITAN OLIVATE
OATMEAL
ALOE
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN
MYELOPEROXIDASE
COCO-CAPRYLATE
DIMETHYL SULFONE
CITRIC ACID MONOHYDRATE
HEMP
ZINC OXIDE
MEDIUM-CHAIN TRIGLYCERIDES
WATER
POLYHYDROXYSTEARIC ACID (2300 MW)
XANTHAN GUM
BETASIZOFIRAN
WILLOW BARK
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73672-981-30 1 TUBE in 1 CARTON contains a TUBE
1 30 mL in 1 TUBE This package is contained within the CARTON (73672-981-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 02/10/2020
Labeler — HEMPFUSION, INC. (117152485)
Establishment
Name Address ID/FEI Operations
Universal Packaging Systems, Inc. (DBA Paklab) 177711082 manufacture (73672-981)

Revised: 03/2021 HEMPFUSION, INC.

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