Alopel Foam

Drug Labeling and Warnings

Drug Details [pdf]

ALOPEL FOAM- glycerin aerosol, foam 
Catalysis, SL

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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Alopel Foam

ACTIVE INGREDIENTS PURPOSE

Glycerin 0.54%.................... Skin Protectant

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep our of the eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children

Children under 6 months: as a doctor.

WARNINGS

• When using this product
• Avoid contact with eyes
• Keep out of reach of children. In case of overdose get medical help or Contact a Poison Control Center right away.

Warnings

Keep out of reach of children

Questions or comments?

+ 34 913456902 M-F 9:00 am to 5:00 pm

Other Information

. keep the product in a cool and dry place

Directions

Apply one or 2 time a day onto the affected areas. Massage for 30 seconds until the foam is absorbed.

• Do not wash or rinse the scalp for three hours after the application of the product

• Apply one or 2 time a day onto the affected areas. Massage for 30 seconds until the foam is absorbed.
• Do not wash or rinse the scalp for three hours after the application of the product

Uses

• Apply one or 2 time a day onto the affected areas. Massage for 30 seconds until the foam is absorbed.
• Do not wash or rinse the scalp for three hours after the application of the product

Inactive Ingredients

Aqua, Isobutane, Alcohol Denat., Butylene Glycol, Propylene Glycol, Propane, Phenoxyethanol, Glycerin, Cocamidopropyl Betaine, Rosmarinus Officinalis Leaf Extract, Salvia Officinalis Leaf Extract , Urtica Dioica Leaf Extract , Dextran, Polyquaternium-11, Pinus Sylvestris, Bud extract , PEG/PPG-20/6 Dimethicone, Camellia Sinensis Leaf Extract , Panthenol , Ethylhexylglycerin, PPG-26-Buteth-26, Camphor, PEG-40 Hydrogenated Castor Oil , Butane, Acetyl Tetrapeptide-3, Trifolium Pratense Flower Extract , Sophora Angustifolia Root Extract, Hydroxypropyl Cyclodextrin , Sodium Benzoate , Biotin, Caprylyl Glycol , Potassium Sorbate, Chamomilla Recutita Flower Extract, Arnica Montana Flower Extract, Lamium Album Extract, Nasturtium Officinale Extract, Arctium Majus Root Extract, Citrus Limon Peel Extract, Hedera Helix Leaf Extract, Calendula Officinalis Flower Extract, Tropaeolum Majus Flower Extract,, Apigenin, Oleanolic Acid, Biotinoyl Tripeptide-1 , Sodium Hyaluronate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Triisopropanolamine

Uses

• Helps to the revitalizes the scalp and strengh the hair
• Protect against negative effect of the stress in the scalp and skin

Package Label

Tube

ALOPEL FOAM 
glycerin aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64539-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.54 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)	0.29 mg  in 1 mL
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)	0.27 mg  in 1 mL
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)	0.09 mg  in 1 mL
PINUS SYLVESTRIS LEAFY TWIG (UNII: Q1RGP4UB73)	0.927 mg  in 1 mL
PEG/PPG-20/6 DIMETHICONE (UNII: PWZ7N4UIKE)	0.918 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	72.697 mg  in 1 mL
CAMPHOR, (-)- (UNII: 213N3S8275)	0.045 mg  in 1 mL
LIQUID PETROLEUM (UNII: 6ZAE7X688J)	2.232 mg  in 1 mL
PANTHENOL (UNII: WV9CM0O67Z)	0.09 mg  in 1 mL
BIOTIN (UNII: 6SO6U10H04)	0.009 mg  in 1 mL
PROPANEDIOL (UNII: 5965N8W85T)	2.569 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.574 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.063 mg  in 1 mL
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)	0.405 mg  in 1 mL
DIMETHYL DISULFIDE (UNII: 3P8D642K5E)	0.038 mg  in 1 mL
DEXTRAN 40 (UNII: K3R6ZDH4DU)	0.18 mg  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.123 mg  in 1 mL
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)	0.054 mg  in 1 mL
ACETYL TETRAPEPTIDE-3 (UNII: D1HW9N9QBX)	0.225 mg  in 1 mL
TRIFOLIUM PRATENSE LEAF (UNII: 612YOZ36DG)	0.225 mg  in 1 mL
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)	0.018 mg  in 1 mL
CITRUS LIMON WHOLE (UNII: EEI224A33Y)	0.0227 mg  in 1 mL
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)	0.0227 mg  in 1 mL
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)	0.0227 mg  in 1 mL
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)	0.081 mg  in 1 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH)	0.045 mg  in 1 mL
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)	0.008 mg  in 1 mL
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)	0.0003 mg  in 1 mL
BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)	0.054 mg  in 1 mL
ISOBUTANE (UNII: BXR49TP611)	7.229 mg  in 1 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)	4.312 mg  in 1 mL
TROPAEOLUM MAJUS FLOWER (UNII: 7FV667B00B)	0.0227 mg  in 1 mL
APIGENIN (UNII: 7V515PI7F6)	0.135 mg  in 1 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	0.004 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	3.375 mg  in 1 mL
CHAMOMILE (UNII: FGL3685T2X)	0.027 mg  in 1 mL
ARNICA MONTANA ROOT (UNII: MUE8Y11327)	0.027 mg  in 1 mL
LAMIUM ALBUM (UNII: 046Y1357I6)	0.027 mg  in 1 mL
NASTURTIUM OFFICINALE (UNII: YH89GMV676)	0.027 mg  in 1 mL
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)	0.027 mg  in 1 mL
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)	0.018 mg  in 1 mL
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)	0.29 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M)	7.2 mg  in 1 mL
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	0.54 mg  in 1 mL
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)	0.175 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64539-013-02	1 in 1 BOX	03/03/2018
1	NDC: 64539-013-01	100 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	part347	03/03/2018	01/01/2019

Labeler - Catalysis, SL (862795119)

Registrant - Catalysis, SL (862795119)

Establishment
Name	Address	ID/FEI	Business Operations
Catalysis, SL		862795119	manufacture(64539-013)

Revised: 6/2019

Document Id: 8a539ab8-b46e-05c1-e053-2a95a90ac33c

34390-5

Set id: 66899a37-0a37-63d1-e053-2a91aa0a1e02

Version: 3

Effective Time: 20190602

 

Catalysis, SL