earth's care ®

earth's care ®
SPL v5
SPL
SPL Set ID ba65f58a-d590-498a-b8e7-a3d78935d880
Route
topical
Published
Effective Date 2022-02-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (natural) (0.5 g) menthol, unspecified form (1 g)
Inactive Ingredients
benzyl alcohol polyglyceryl-3 dicitrate/stearate caprylic/capric triglyceride glyceryl monostearate cetyl alcohol almond oil heptyl undecylenate jojoba oil avocado oil .alpha.-bisabolol, (+/-)- argan oil phenoxyethanol ethylhexylglycerin tocopherol ginger aloe vera leaf cetyl hydroxyethylcellulose (350000 mw) potassium hydroxide glycerin shea butter water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2020-08-28

Description

Drug Facts


Medication Information

Warnings
  • For external use only
Active Ingredient

Camphor 0.5% external analgesic

Menthol 1% external analgesic

Uses

for the temporary relief of pain and itching associated with minor skin irritations such as poison ivy/oak/sumac, sunburn, insect bites, and minor cuts and scrapes.

Directions

Adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Inactive Ingredients

Aloe barbadensis (aloe vera ) leaf juice powder, alpha-bisabolol, Argania spinosa (argan) kernel oil, benzyl alcohol, Butyrospermum parkii (shea) butter, caprylic/capric triglyceride, cetyl alcohol, cetyl hydroxyethylcellulose, ethylhexylglycerin, glycerin, glyceryl stearate, heptyl undecylenate, Persea gratissima (avocado) oil, phenoxyethanol, polyglyceryl-3 dicitrate/stearate, potassium hydroxide, Prunus amygdalus dulcis (sweet almond) oil, purified water, Simmondsia chinensis (jojoba) seed oil, tocopherol (natural vitamin E), Zingiber officinale (ginger) root extract.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients Purpose
Camphor 0.5% External analgesic
Menthol 1% External analgesic
Questions

1-888-602-6380

earths-care.com

Distributed by Earth's Care Natural Products, Inc.

Long Beach, California 90805, USA

When Using This Product
  • avoid contact with eyes
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding

If pregnant or breast feeding

ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel 237 Ml Bottle Label

Steroid-Free

EARTH'S

CARE ®

• PARABEN

FREE•

Anti-Itch

Lotion

Natural Camphor & Menthol

Proven itch relief for:

Insect Bites ♦

Poison Ivy/Oak/sumac ♦

Sunburn ♦

with

Shea Butter

and Almond Oil

1%

FOR THE

PLANET SM

MEMBER

8 FL. OZ. (237 mL)


Structured Label Content

Warnings
  • For external use only
Active Ingredient (55106-9)

Camphor 0.5% external analgesic

Menthol 1% external analgesic

Uses

for the temporary relief of pain and itching associated with minor skin irritations such as poison ivy/oak/sumac, sunburn, insect bites, and minor cuts and scrapes.

Directions

Adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Inactive Ingredients (Inactive ingredients)

Aloe barbadensis (aloe vera ) leaf juice powder, alpha-bisabolol, Argania spinosa (argan) kernel oil, benzyl alcohol, Butyrospermum parkii (shea) butter, caprylic/capric triglyceride, cetyl alcohol, cetyl hydroxyethylcellulose, ethylhexylglycerin, glycerin, glyceryl stearate, heptyl undecylenate, Persea gratissima (avocado) oil, phenoxyethanol, polyglyceryl-3 dicitrate/stearate, potassium hydroxide, Prunus amygdalus dulcis (sweet almond) oil, purified water, Simmondsia chinensis (jojoba) seed oil, tocopherol (natural vitamin E), Zingiber officinale (ginger) root extract.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients Purpose
Camphor 0.5% External analgesic
Menthol 1% External analgesic
Questions

1-888-602-6380

earths-care.com

Distributed by Earth's Care Natural Products, Inc.

Long Beach, California 90805, USA

When Using This Product (When using this product)
  • avoid contact with eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

If pregnant or breast feeding

ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel 237 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label)

Steroid-Free

EARTH'S

CARE ®

• PARABEN

FREE•

Anti-Itch

Lotion

Natural Camphor & Menthol

Proven itch relief for:

Insect Bites ♦

Poison Ivy/Oak/sumac ♦

Sunburn ♦

with

Shea Butter

and Almond Oil

1%

FOR THE

PLANET SM

MEMBER

8 FL. OZ. (237 mL)


Advanced Ingredient Data


Raw Label Data

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