EARTHS CARE ANTI-ITCH (camphor- natural, menthol cream

EARTHS CARE ANTI-ITCH by

Drug Labeling and Warnings

EARTHS CARE ANTI-ITCH by is a Otc medication manufactured, distributed, or labeled by DLC Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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 the 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

beeswax, Butyrospermum parkii (shea) butter, cetearyl glucoside, cetyl alcohol, citric acid, glycerin, glyceryl stearate, heptyl undecylenate, hydrogenated castor oil, Oryza sativa (rice) bran extract, phenoxyethanol, potassium sorbate, Prunus amygdalus dulcis (sweet almond) oil, purified water, sodium stearoyl glutamate, sodium stearoyl lactylate, stearic acid, xanthan gum

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 68 g Tube Box

Steroid-Free

EARTH'S
CARE™

PARABEN
FREE

Anti-Itch
Cream

Natural Camphor & Menthol

Proven itch relief for:

Insect Bites

Poison Ivy/Oak/Sumac

Sunburn

with Shea Butter and Almond Oil

1%
FOR THE
PLANET
MEMBER

2.4 OZ. (68 g)

INGREDIENTS AND APPEARANCE

EARTHS CARE ANTI-ITCH 
camphor (natural), menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24286-1558
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	.5 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
RICE BRAN (UNII: R60QEP13IC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALMOND OIL (UNII: 66YXD4DKO9)
WATER (UNII: 059QF0KO0R)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24286-1558-2	1 in 1 BOX	10/30/2013
1		68 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 24286-1558-1	1 in 1 BOX	05/01/2015
2		28 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 24286-1558-3	2.8 g in 1 POUCH; Type 0: Not a Combination Product	05/01/2015
4	NDC: 24286-1558-4	6 g in 1 JAR; Type 0: Not a Combination Product	05/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	10/30/2013

Labeler - DLC Laboratories, Inc. (093351930)

Establishment
Name	Address	ID/FEI	Business Operations
DLC Laboratories, Inc.		093351930	MANUFACTURE(24286-1558) , LABEL(24286-1558)