Earths Care Anti-Itch: Package Insert and Label Information

EARTHS CARE ANTI-ITCH- camphor (natural) and menthol, unspecified form lotion
DLC Laboratories, 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.

Drug Facts

Active ingredients Purpose
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.

Warnings

  • For external use only

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, 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.

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

Questions

1-888-602-6380

Distributed by:
Earth’s Care Natural Products, Inc.
Long Beach, California 90805 USA

PRINCIPAL DISPLAY PANEL — 237 mL Bottle Label

Steroid-Free — Allergy-Tested

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)

Anti-Itch-Lotion
(click image for full-size original)
EARTHS CARE ANTI-ITCH
camphor (natural) and menthol, unspecified form lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1576
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 0.5 g in 100 mL
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GINGER
ALOE VERA LEAF
CETYL HYDROXYETHYLCELLULOSE (350000 MW)
POTASSIUM HYDROXIDE
GLYCERIN
SHEA BUTTER
GLYCERYL MONOSTEARATE
CETYL ALCOHOL
ALMOND OIL
MEDIUM-CHAIN TRIGLYCERIDES
HEPTYL UNDECYLENATE
TRICAPRILIN
TRICAPRIN
JOJOBA OIL
AVOCADO OIL
.ALPHA.-BISABOLOL, (+/-)-
ARGAN OIL
OATMEAL
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
TOCOPHEROL
Product Characteristics
Color white (Off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24286-1576-8 237 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 08/28/2020
Labeler — DLC Laboratories, Inc. (093351930)
Establishment
Name Address ID/FEI Operations
DLC Laboratories, Inc. 093351930 manufacture (24286-1576), label (24286-1576)

Revised: 11/2022 DLC Laboratories, Inc.

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